U.S. patent number 6,981,977 [Application Number 10/045,544] was granted by the patent office on 2006-01-03 for body fluid cartridge exchange platform device.
This patent grant is currently assigned to Atrium Medical Corporation. Invention is credited to Steve A. Herweck, Paul Martakos.
United States Patent |
6,981,977 |
Herweck , et al. |
January 3, 2006 |
Body fluid cartridge exchange platform device
Abstract
An apparatus for establishing a re-usable, recurring, mechanical
connection to an organ within a patient is provided. A body fluid
cartridge exchange platform device includes a hollow cartridge
platform housing with a first end having an opening. The platform
housing can additionally have a second end with a second opening.
The first opening and the second opening facilitate insertion of an
exchange cartridge insert that sealably engages the housing. The
first opening and the second opening additionally facilitate
removal of the exchange cartridge insert. The exchange cartridge
insert can facilitate a flow path between a first leg and a second
leg of the platform housing, and can facilitate a flow path between
the platform housing and an external location for medical procedure
or drug delivery purposes.
Inventors: |
Herweck; Steve A. (Nashua,
NH), Martakos; Paul (Pelham, NH) |
Assignee: |
Atrium Medical Corporation
(Hudson, NH)
|
Family
ID: |
21938514 |
Appl.
No.: |
10/045,544 |
Filed: |
October 26, 2001 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20030083678 A1 |
May 1, 2003 |
|
Current U.S.
Class: |
606/153;
604/175 |
Current CPC
Class: |
A61M
1/3653 (20130101); A61M 1/3659 (20140204); A61M
1/3661 (20140204); A61M 39/0247 (20130101); A61M
1/285 (20130101); A61M 2039/0258 (20130101) |
Current International
Class: |
A61B
17/08 (20060101) |
Field of
Search: |
;606/153,155,108,109
;604/175,29,43,93.01 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
7-255854 |
|
Oct 1995 |
|
JP |
|
WO 98/30249 |
|
Jul 1998 |
|
WO |
|
WO 99/20338 |
|
Apr 1999 |
|
WO |
|
WO 98/61093 |
|
Dec 1999 |
|
WO |
|
WO 99/62576 |
|
Dec 1999 |
|
WO |
|
WO 00/76577 |
|
Dec 2000 |
|
WO |
|
WO 01/21251 |
|
Mar 2001 |
|
WO |
|
WO 01/89607 |
|
Nov 2001 |
|
WO |
|
WO 01/89607 |
|
Nov 2001 |
|
WO |
|
WO 02/062414 |
|
Aug 2002 |
|
WO |
|
Other References
Vasca, Inc. "Introducing LifeSite: The First Subcutaneous
Hemodialysis Access System" Platform Access Device PAD And
Accessories Jan. 30, 2001. cited by other.
|
Primary Examiner: Woo; Julian W.
Attorney, Agent or Firm: Lahive & Cockfield, LLP
Claims
What is claimed is:
1. A body fluid cartridge exchange platform device, comprising: a
tubular cartridge insert and a hollow tubular platform housing
having a generally oval cross-section, a first end with a first
opening and a second end with a second opening, wherein said first
opening and said second opening facilitate insertion of said
tubular cartridge insert that sealably engages inside the platform
housing, and said first opening and said second opening facilitate
bi-directional installation through either of said first opening
and said second opening and bi-directional removal of said tubular
cartridge insert through either of said first opening and said
second opening regardless of which opening said tubular cartridge
insert was installed through.
2. The device of claim 1, further comprising a small diameter first
hollow leg member having an internal diameter, the leg member
suitable for extending from the platform housing through skin of a
patient for facilitating body fluid communication between an organ
and at least a portion of the platform housing and tubular
cartridge insert.
3. The device of claim 2, wherein the first hollow leg member
supports the platform housing removed from the skin of the
patient.
4. The device of claim 2, wherein the tubular cartridge insert
provides a substantially arcuate flow path through the platform
housing.
5. The device of claim 2 further comprising a second hollow leg
member extending from the platform housing and penetrating through
the skin of the patient and completing a fluid communication flow
path extending between the first hollow leg member and the second
hollow leg member through the tubular cartridge insert.
6. The device of claim 5, wherein the first and second hollow leg
members include multiple internal lumens that communicate with the
platform housing.
7. The device of claim 6, wherein the multiple internal lumens are
adapted to communicate with multiple organs.
8. The device of claim 7, further comprising an external
communicating passageway coupled to one of the openings of the
platform housing and adapted to provide communication between the
organ and an external destination.
9. The device of claim 8, wherein the external destination is
adapted to provide a mechanism of drug delivery to supply one or
more drugs to the organ.
10. The device of claim 5, wherein the first and second hollow leg
members have a diameter of less than about 10 mm.
11. The device of claim 5, wherein the first and second hollow leg
members each further comprise a microporous cell penetrable cuff
disposed at a sub-dermal end of the first and second hollow leg
members when implanted in a patient.
12. The device of claim 5, further comprising a bioactive coating
disposed on at least a portion of the flow path between the first
hollow leg member and the second hollow leg member through the
tubular cartridge insert.
13. The device of claim 2, wherein the tubular cartridge insert
provides a flow path through the platform housing and wherein the
flow path has a diameter varying from a diameter relatively greater
than an internal diameter of the first hollow leg member to
substantially a same diameter as the internal diameter of the first
hollow leg member.
14. The device of claim 2, wherein multiple tubular cartridge
inserts are sealably engaged within the platform housing in
alignment and communicate with the leg member.
15. The device of claim 1, wherein the tubular cartridge insert
includes a locking mechanism for locking the tubular cartridge
insert into a desired alignment within the platform housing.
16. The device of claim 15, wherein the locking mechanism is a
flexible tab that extends from the tubular cartridge insert.
17. The device of claim 16, wherein the platform housing includes a
receiver for receiving the flexible tab to hold the tubular
cartridge insert in a desired alignment.
18. The device of claim 1, further comprising at least one marking
disposed on at least one of the tubular cartridge insert and the
platform housing that is suitable as an insertion direction
indicator for the tubular cartridge insert.
19. An access device for providing access to internal organs,
comprising: a housing having a generally oval cross-section, a
first opening at a first end and a second opening at a second end;
and a cartridge suitable for sealingly engaging an interior of the
housing, the cartridge being insertable through either of the first
opening and the second opening and removable through either of the
first and second openings regardless of which opening the cartridge
was inserted through.
20. The device according to claim 19, further comprising a first
port and a second port disposed through a wall of the housing.
21. The device according to claim 20, further comprising a first
leg having at least a first passage in communication with the first
port and a second leg having at least a second passage in
communication with the second port.
22. The device according to claim 21, wherein the first leg extends
in a staggered and divergent manner from the second extending leg
along the wall of the housing.
23. The device according to claim 21, further comprising a channel
disposed within the cartridge.
24. The device according to claim 23, wherein the channel completes
a flow path between the first passage and the second passage
through the first and second ports.
25. The device according to claim 24, further comprising at least
one external passage in communication with the channel of the
cartridge, the external passage being suitable for at least one of
introducing and removing a substance.
26. The device according to claim 24, further comprising a first
channel port and a second channel port at opposite ends of the
channel within the cartridge.
27. The device according to claim 26, wherein a distance between
the first channel port and a first end of the cartridge is greater
than a diameter of the first channel port.
28. The device according to claim 27, wherein a distance between
the second channel port and a second end of the cartridge is
greater than a diameter of the second channel port.
29. The device according to claim 24, further comprising a
bioactive coating disposed on at least a portion of the flow
path.
30. The device according to claim 21, wherein the first and second
legs are configured to penetrate skin of a patient.
31. The device according to claim 21, wherein the first and second
legs are configured to support the housing distally from a surface
of skin of a patient.
32. The device according to claim 21, wherein the first and second
legs are minimally invasive when implanted in a patient.
33. The device according to claim 21, wherein the first and second
legs each have an outer diameter of less than about 10 mm.
34. The device according to claim 21, wherein the first and second
legs further comprise a microporous cell penetrable cuff for
sub-dermally anchoring the first and second legs below a skin
surface of a patient.
35. The device according to claim 21, wherein the first passage of
the first leg and the second passage of the second leg are
configured to be placed in fluid communication with the organs.
36. The device according to claim 19, wherein the housing is
generally tubular.
37. The device according to claim 19, further comprising a locking
mechanism suitable for fastening the cartridge in place within the
housing.
38. The device according to claim 19, wherein the cartridge is
suitable for connection with an external drug source for supplying
at least one drug to the internal organs.
39. The device of claim 19, further comprising at least one marking
disposed on at least one of the cartridge and the housing that is
suitable as an insertion direction indicator for the cartridge.
40. A body fluid cartridge exchange platform device, comprising: a
tubular cartridge insert, a hollow tubular platform housing having
a generally oval cross-section, a first end with a first opening
and a second end with a second opening, wherein said first opening
and said second opening facilitate insertion of said tubular
cartridge insert that sealably engages inside the platform housing,
and said first opening and said second opening facilitating
bi-directional installation through either of said first opening
and said second opening and bi-directional removal of said tubular
cartridge insert through either of said first opening and said
second opening regardless of which opening the tubular cartridge
insert was installed through; and a cartridge insert tool for
executing a bi-directional cartridge insert installation and
removal.
41. The device of claim 40, wherein the cartridge insert tool
further comprises at least one marking disposed on at least the
cartridge insert tool and the housing that is suitable as an
insertion direction indicator for the tubular cartridge insert.
42. An access device for providing access to internal organs,
comprising: a housing comprising having a first opening at a first
end, a second opening at a second end, a first port disposed
through a wall of the housing, a second port disposed through a
wall of the housing, a first leg having at least a first passage in
communication with the first port and a second leg having at least
a second passage in communication with the second port, wherein the
first leg extends in a staggered and divergent manner from the
second extending leg along the wall of the housing; and a cartridge
suitable for sealingly engaging an interior of the housing, the
cartridge being insertable through either of the first opening and
the second opening and removable through either of the first and
second openings regardless of which opening the cartridge was
inserted through.
43. An access device for providing access to internal organs,
comprising: a housing having a first opening at a first end, a
second opening at a second end a first leg having at least a first
passage in communication with the first port and a second leg
having at least a second passage in communication with the second
port; a cartridge suitable for sealingly engaging an interior of
the housing, the cartridge being insertable through either of the
first opening and the second opening and removable through either
of the first and second openings regardless of which opening the
cartridge was inserted through, and a channel disposed within the
cartridge that completes a flow path between the first passage and
the second passage through the first and second ports and forming a
first channel port and a second channel port at opposite ends of
the channel within the cartridge, wherein a distance between the
first channel port and a first end of the cartridge is greater than
a diameter of the first channel port.
Description
FIELD OF THE INVENTION
The present invention relates to a minimally invasive surgical
implant that functions as an externally connectable body fluid
cartridge exchange platform device.
BACKGROUND OF THE INVENTION
A number of patients today undergo recurring medical procedures
requiring repeated skin penetrating access to the patient's
internal hollow organs, including organs contained within the
mediastinal, chest, abdominal and peritoneal cavities, and organs
forming the patient's circulatory system, i.e., blood vessels. One
such recurring medical procedure is hemodialysis. Currently, over
one million patients worldwide suffer from End State Renal Disease
(ESRD) conditions and require some form of daily or thrice weekly
dialysis treatment via needle or catheter access. Peritoneal
Dialysis is one form of dialysis treatment requiring needle or
catheter access whereby fluids placed into the peritoneal cavity
via a temporary or permanently placed access catheter provide
osmotic transfer of blood containing toxins into solutions pumped
into and removed from within the peritoneal organ cavity. A second
form of dialysis treatment is a direct blood filtering process,
whereby a needle or catheter is placed directly into a vein or
artery, and through a series of connecting tubing, blood is removed
and re-circulated back into the patient after filtration of the
blood. These two hemodialysis procedures are the most common means
for metabolic toxin removal from body fluids when a patient
experiences total or bilateral renal failure.
Without needle or indwelling catheter organ access for dialysis,
there is no physical connection means to conduct dialysis toxin
removal, and the ESRD patients would die within days of total renal
failure. Hence, the insertion method and form of dialysis
connection access relates directly to the patient's ability to have
body fluids contained within an internal organ communicate and be
safely connected "externally outside the body" for the purposes of
blood hemofiltration.
Because both types of dialysis treatment techniques discuss above
require trained medical personnel for needle or catheter access and
the administration of the actual external dialysis filtration
process, there are significant healthcare hazards for both the
patient and healthcare worker associated with such traditional
needle access methods. Most ESRD patients must be transported to a
public dialysis treatment center for treatment.
Some form of needle or indwelling catheter organ access is required
as a physical connection means to conduct dialysis toxin removal.
The insertion method employed and the form of dialysis access used
affects the patient's ability to have body fluids contained within
an internal organ communicate and be safely connected externally
outside the body for the purpose of blood hemofiltration.
Most ESRD patients must travel to a public dialysis treatment
center for treatment. Financial and logistical considerations are
current sources of difficulty for an ESRD patient in obtaining
necessary dialysis treatments. Consequently, any young or new ESRD
patient must be placed into a treatment lottery, and may end up
having to go for dialysis treatments at inconvenient hours (e.g.,
2:00 AM to 6:00 AM). In addition, many patients are only being
treated for a maximum of 3 4 hours per visit, and only 3 times per
week.
Recent published studies have shown that "daily dialysis" treatment
techniques bring many of these ESRD patient's blood toxicity levels
down to normal, non-toxic levels. Thus, dialysis treatment
approaching 3 4 hours per visit, three times per week, is
inadequate for lowering patient toxicity levels to normal levels.
Other studies have concluded that more frequent dialysis improves
patient health and well-being, enabling patients to be more
productive and lead a more independent life, while reducing
reliance on medications and hours spent in the hospital. Reduction
of time spent in hospitals helps the healthcare industry in that
patient populations are growing at approximately 6% 7% annually,
which could lead to a burden on our health care facilities.
Without a kidney transplant, the average life span of even the
healthiest patient who has experienced total renal failure, is only
about 5 years. It is now known from published clinical studies that
when a patient can be treated "daily" with dialysis, even with
shorter, less efficient periods of time on the dialysis machine,
those individuals' blood toxicity levels return to near normal, and
remain almost equivalent to their prior functional kidney
performance levels. Often, the patients receiving daily dialysis no
longer require the expense of erythropoietin-type medications to
help stabilize their red blood cells during periods of blood
toxicity. Erythropoietin is a significant cost to the patients, and
it is required for dialysis patients who need to extend the
survival half-life of their oxygen carrying red blood cells,
especially under extreme blood toxicity conditions. Current
indications are that more cost-effective daily dialysis will extend
the survival rate of ESRD patients from a projected life expectancy
of 5 years with 3 4 treatments per week, to about 20 years or
more.
One of the common denominators relating to treatment cost with the
ESRD patients is the need for a trained healthcare worker to clean,
prepare, and install a needle, guide wire, or catheter into the
body fluid organ access site for external connection of the
dialysis tubing sets to the dialysis machine. Most dialysis
patients require insertion of two large gauge dialysis needles
directly through the skin and precisely into the body fluid organ,
surgically installed graft, vein, or artery. Such a requirement
means that for a patient to undergo dialysis treatment, they must
travel to a center for a professionally trained healthcare worker
to find the correct subcutaneous blood vessel location and then
insert the access device needle or catheter precisely into the
blood containing organ, without significantly damaging either the
internal or external vessel wall surface. Without precision needle
or catheter placement, a patient can bleed to death from a poorly
placed needle or catheter. Other possible complications include
total occlusion of the vessel, graft, or connection setup,
requiring total access device removal and reinstallation elsewhere.
Another common complication from needle or catheter access is the
formation of a massive subcutaneous hematoma, which can become
infected. The hematoma can require surgical intervention to drain,
de-clot and repair, and sometimes results in death due to their
already toxic blood conditions and compromised autoimmune
protection system.
There are a number of complicating issues relating to the process
of repeatedly sticking and cannulating a patient's circulatory
organ system and removing/returning blood back to the patient. One
significant complication is the need for maintenance of a sterile
installation and connection technique for all components involved
in establishing dialysis access through the patient's skin and into
the hollow targeted organ, as well as connection to the dialysis
tubing set, filter, and dialysis pump apparatus. Another
complication is the inability of a particular artery or vein to be
repeatedly cannulated or punctured at substantially the same
convenient needle or catheter access site, due to vessel trauma,
exit wound inflammation, dialysis graft complications, and/or
enlarged needle hole formation resulting in massive needle hole
bleeding/ hematoma formation. Repeated dialysis needle punctures
create unwanted scar tissue formation and infection. Both
conditions are directly related to repetitive needle and catheter
cannulation through the skin. Such large gauge needle cannulation
complications are uncomfortable for the patient and the healthcare
worker, due to the associated pain of additional needle sticks.
Infection complications of these needle access sites are difficult
to treat, because of the constant migratory effects of nosocomial
infections, which have been well documented to routinely originate
from direct contact with topical skin sourced Staphylococcocus
bacteria. These frequently occurring needle access complications
often require surgical intervention to repair, reconstruct, or
remove the affected vessel organ, in addition to requiring extended
hospital admission and costly medication treatment with IV
medications.
One approach to help solve some of these needle and indwelling
catheter access complications, can be found in PCT Patent
Application No. WO 99/20338 ("the '338 application"). The device of
the '338 application is described as being an implantable metal
port housing which is surgically installed within the body of a
patient. The device includes a main body having two openings for
connecting the implanted housing to blood vessels under the skin
and or under the dermal layer of the patient. Implantation of the
device requires a large surgical incision in the skin, separation
or removal of a portion of the skin, insertion of the metal alloy
housing or port can, attachment of the blood vessels to the
implanted housing, and subsequent healing of the skin wound around
the entire perimeter of the main housing body. The main housing
body and blood vessel connecting portions of this device reside
entirely below the dermal skin surface.
The device described in the '338 application has a main housing
body and blood vessel connection means radiating from this housing
that are positioned below the dermal skin layer, and may be subject
to significant amounts of skin trauma, disruption, and inflammation
surrounding the implanted device.
The main body of the device of the '338 application requires a flat
or planar sealing surface to which a flat planar protective body
lid or connecting member lid member seals. The lid then mounts to
the housing via linear holding elements that press down onto and
deflect holding means on the protective body to establish a
sealable surface with the main housing sealing surface. The lid
holding means are described as being sideways-directed linear
flanges to cooperate with holding elements on the main body. The
'338 application further states that the holding elements must be
deflected to function. The holding elements, as described, push
down and deflect the linear flanges to keep tension on the flat and
planar protective body lid to maintain a sealable surface. This
holding element and the holding means are the only described
mechanisms for maintaining a sealable surface to the main housing's
flat and planar sealing surface. To change a lid, an attachable
linear slide holder, tool, or cassette, fits over an exposed
portion of the indwelling main body outer surface and protruding
holding elements to allow the simultaneous change-out of the
protective body lid as it is guided by the straight planar holding
elements located on top of the exposed outer surface of the main
body housing. The protective body lid is displaced in a one-way
linear push fashion by another connecting member lid with identical
holding means using mechanical lever assistance in the holder,
tool, or cassette device. The linear slide tool with mechanical
lever assistance for protective lid replacement or exchange is then
removed from the main body with the used protective lid held onto
the skin contacting surface of the linear slide tool for their
combined disposal.
As a large indwelling implant, the access port design of the '338
device has no means for remote incision placement for the blood
vessel attachment legs or connection means. The device housing and
blood vessel connection legs must sit directly on top of, or
within, the surgically exposed sub-dermal tissue location.
Installation connection of an outwardly directed tube connection
means of the '338 device requires blunt dissection into the
sub-dermal tissue directly under, or to, the immediate side area of
the installed main housing body, clearly below the surface of the
skin. The main housing body of the '338 device after surgical
installation may also be sensitive to touch and/or be painful to
topical depression or compression by the patient, due to direct
main housing body contact with subdermal tissue, and the potential
for chronic inflammation in, under, and around the neighboring
tissue following implantation. Such compromising issues may be
further exasperated by poor wound tissue healing at both the
housing/dermal skin contact zone, and/or the tissue contact zone
directly under the implanted metal port can, as there is no
disclosure of providing a microporous healable cuff material for
tissue incorporation. With such large non-porous metal surfaces,
there is little or no biological attachment of healing tissue to
help stabilize movement of the main body of the '338 device.
Without healthy remodeled collagen producing tissue growth to help
stabilize the housing of the '338 device, tissue will remain
swollen and inflamed. Due to the potential size requirements to
fabricate a flat and planar sealable surface mechanism, the risk of
dermal compression about the perimeter of the indwelling metal
device could lead to necrosis of the surrounding tissue, which can
only be treated by surgical removal, followed by skin graft
reimplantation to replace the lost dermal skin over the effected
area.
In the presence of any implanted device or sub-dermal wound
infection, aggressive medical treatment for adjacent contacting
tissues about the indwelling structure requires lengthy treatment
periods with powerful intravenous or intramuscular injectable
antibiotics, and/or complete surgical removal of the implant.
Failure to diagnose and treat device-related infections could
easily lead to tissue necrosis in, under, and around the implanted
main body housing. Even if there were no visible or apparent
physical signs of device infection, substantial sub-dermal
inflammation in and around, and directly under the main housing of
the '338 device would over time likely result in subsequent
infection, principally due to the massive amount of tissue healing
and collagen tissue remodeling required to stabilize the non-cell
porous implantable structure. Historically, published studies on
similar implantable metal port structures indicate that recurring
infection and chronic inflammation can also lead to other life
threatening conditions and systemic blood problems, such as
endocarditis, bacteremia/septicemia, and/or hypercoagulation and
thrombosis.
Another known device is described in U.S. Pat. No. 5,474,526. A
substantial portion of the main housing of this device disclosed in
the '526 patent is again implanted completely within the body of
the patient with the exception of an outer rim portion of the main
implanted body housing extending outward through the skin. The '526
device has many of the same device requirements as the '338 device.
An outward coupling means achieves a connection to the housing by
rotation of a stop-cock like connecting member relative to the
housing after axial insertion to one exposed open end of the
indwelling the housing. A coupling means makes the connection
between the artery and vein of the patient and the external
apparatus, such as a dialysis machine. The implanted device is
substantially indwelling to the skin and connected to the blood
vessels by port members which radiate from the main body housing
below the surface of the skin, which essentially results in a
totally subcutaneously implanted device. In similar fashion to the
'338 device, the '526 device is likely to experience significant
displacement of skin and dermal tissue. The same concerns for
infection are likely to occur with this same non-porous metal
housing construction, with bacterial colonization spreading from
one surface plane of the '526 main body housing within the large
installation incision to another indwelling surface plane, followed
by inflammation of the localized tissue around and under the
implantable metal housing. Neither the '338 patent, nor the '526
patent, teach or suggest provisions for limiting the amount of
implantable material surface area for reduced surgical installation
tissue dissection, or tissue disruption. Further, neither the '338
patent device, nor the '526 patent device descriptions provide
design elements or surgical installation considerations for
encouraging remote wound incisions to help improved healing after
implantation or help control or minimize main body housing
infection with such port devices. Additionally, neither patent
describes material specifications for maximizing tissue attachment
to the implanted main body housing for well-anchored, collagen
remodeling dermal tissue.
SUMMARY OF THE INVENTION
There is a need for an implantable organ access device requiring a
minimal amount of disruption to the patient's skin for
implantation, and thus significantly reducing the amount of device
surface area penetrating the skin and creating wounds that require
healing. There is a further need to reduce the material surface
area and size of a surgically installed portion of a body fluid
cartridge exchange platform and to offer a mechanically simplified,
needle less, and easy to use external body fluid organ connection
device. Such a device requires minimal surgical disruption of the
patient's outer dermal and sub-dermal tissue, and thus
significantly reduces the amount of tissue trauma and wound size
for faster, more efficient wound healing. There is a further need
for an implantable tubular cartridge exchange platform mechanism
for external connection and fluid communication means, with a
positive locking and leak-proof connection means to such known
therapeutic body fluid handling devices as a dialysis blood
filtration machine, cardiopulmonary blood oxygenator system,
therapeutic cell washing and blood transfusion processing
equipment, and/or attachment to a long term drug delivery apparatus
for chronic administration of chemotherapeutic agents.
Applicable devices further significantly reduce the amount of
material mass and surface area to be surgically installed below the
surface of a patient's skin to help reduce the risk of bacterial
colonization from occurring in, under, or around, the sub-dermal
implanted portions of the surgically installed device. An elegantly
simple mechanical cartridge exchange platform serves to improve the
safety of repetitive patient dialysis tubing connection, without
the documented patient risks and hazards associated with repetitive
"needle sticking" and/or patient health complications associated
with invasive and repetitive vascular graft or blood vessel
cannulation. Further, such a body fluid cartridge exchange platform
also serves to improve patient safety, and simplify the mechanical
connection process to such internal organs with less wound
complications, which are serious and sometimes life threatening
complications associated with other known implantable metal port
access devices.
The present invention provides solutions to address these needs, in
addition to simplifying access to the patient's body fluid and
external medical treatment connection technique, with a potentially
more cost efficient body fluid cartridge exchange platform device,
that can further expand the clinical use and application of "daily
dialysis" patient care in addition to other needs not specifically
mentioned.
In accordance with one example embodiment of the present invention,
an implantable body fluid cartridge exchange platform device is
provided. The implantable body fluid cartridge exchange platform
device has a hollow cartridge platform housing with a first end
having an opening. The hollow cartridge platform housing
additionally has a second end with a second opening. The first
opening and the second opening facilitate bi-directional insertion
of a tubular cartridge insert that sealably engages inside the
hollow cartridge platform housing. The first opening and the second
opening additionally facilitate bi-directional removal of the
interchangeable tubular cartridge insert.
In accordance with one embodiment of the present invention, the
hollow cartridge platform housing includes a first hollow leg
member having an internal diameter suitable for extending out from
the hollow cartridge platform housing and through the skin of a
patient. The first hollow leg member can have an external
cross-section area of less than 10 mm, causing the member to be a
small diameter skin penetrating element of the hollow cartridge
platform housing. The first hollow leg member facilitates fluid
communication between an internal body fluid organ and the hollow
cartridge platform housing, which resides horizontally above the
surface of the patient's skin. The small diameter first hollow leg
member additionally supports the under surface of the hollow
cartridge platform housing up and away from the surface of the
patient's skin.
In accordance with still another embodiment of the present
invention, a tubular cartridge insert provides an internal
cartridge flow path lumen, channel, or passageway, through a
portion of the tubular cartridge insert. The tubular cartridge
insert's internal cartridge flow path lumen has an internal flow
path diameter dimension varying from a diameter dimension
relatively greater than the internal diameter dimension of the
first hollow leg member to substantially a same diameter dimension
as the internal diameter of the first hollow leg member. In
addition to the first hollow leg member, a second hollow leg member
is provided extending out from the hollow cartridge platform
housing through the skin of the patient. The second hollow leg
member can have an external diameter cross-sectional area of less
than 10 mm, causing the second hollow leg member to be considered a
small diameter skin penetrating element of the hollow cartridge
platform housing. The second hollow leg member completes a fluid
communication path extending between the first hollow leg member
and the second hollow leg member through the internal cartridge
flow path lumen of the tubular cartridge insert. The second hollow
leg member additionally supports the under side surface of the
hollow cartridge platform housing up and off the surface of the
patient's skin.
In accordance with further embodiments of the present invention,
the first and second hollow leg members include multiple internal
lumens that communicate with one or more tubular cartridge insert
internal cartridge flow path lumens. The multiple internal
cartridge flow path lumens can communicate with one or more
discretely different organ locations or sections, and/or
communicate with two or more distinctly different body fluid
organs.
In accordance with still another embodiment of the present
invention, the tubular cartridge insert includes a locking
mechanism for positively locking and/or containing the tubular
cartridge insert into a fixed location within the hollow cartridge
platform housing. Several different mechanical methods can be used
to temporarily lock, contain, or hold the tubular cartridge insert
into a desired position within the hollow cartridge platform
housing. One example of a temporary locking mechanism can take the
form of, e.g., a flexible tab element that extends from and beyond
a sealable surface portion of the tubular cartridge insert that is
located inside a portion of the hollow cartridge platform housing.
A portion of the locking tab element can be made to fit into a
receiver located in a portion of the hollow cartridge platform
housing wall surface once the tubular cartridge insert reaches a
desired fixed position within the hollow cartridge platform
housing. The hollow cartridge platform housing can include a
receiver for accommodating, containing, and positively locking the
flexible tab in a temporary and fixed position to hinder movement
of the tubular cartridge insert once it has obtained its intended
position within the hollow cartridge platform housing.
In accordance with another embodiment of the present invention, one
or more tubular cartridge inserts sealably engage with a portion of
an inside surface of the hollow cartridge platform housing with
internal fluid path port opening alignment with each of the hollow
leg members, to provide body fluid communication with each of the
first and second hollow leg members.
In accordance with still another embodiment of the present
invention, the tubular cartridge insert further includes an
external communicating passageway or lumen, which extends from a
first port opening along the internal cartridge flow path lumen and
out through a second port opening on one end of a non-sealable
tubular cartridge insert surface.
In accordance with yet another embodiment of the present invention,
a body fluid cartridge exchange platform device for providing
external needleless connection and fluid communication to internal
body fluid organs is provided. The cartridge exchange platform
device includes a tubular housing having a first opening at a first
end and a second opening at a second end. A tubular exchange
cartridge insert sealably engages a portion of the hollow cartridge
platform housing to maintain a leak-proof seal for all body fluid
communicating internal flow paths, channels, and/or passageways
within the hollow cartridge platform housing. The tubular exchange
cartridge insert is installed right side up to attain body fluid
communication after installation inside the hollow cartridge
platform housing and therefore is made to prevent incorrect
installation, by the installation assistance of a second,
pre-loaded cartridge insert exchange tool or device. The cartridge
insert exchange tool is also made for bi-directional movement into
and out of the tubular cartridge platform housing, including
installation and/or removal through either of end of the first and
second openings of the cartridge platform housing.
In accordance with another embodiment of the present invention, the
hollow cartridge platform housing further includes a first hollow
leg member having at least a first distal port opening in
communication with a first proximal port opening, and a second
hollow leg member having at least a second distal port opening in
communication with a second proximal port opening. The first hollow
leg member and the second hollow leg member can each extend outward
from an outer wall surface of the hollow cartridge platform
housing. The first hollow leg member position location can be
staggered and divergent away from the second hollow leg member
along the same wall surface of the cartridge platform housing.
In accordance with still another embodiment of the present
invention, the hollow cartridge platform housing further includes a
first leg member having at least a first open passageway, an
internal flow path, or channel, in communication with the first
port opening and a second leg member having at least a second open
passageway in communication with the second port opening. The first
leg member and the second leg member can each extend outward from
the outer wall surface of the hollow cartridge platform housing.
The first leg member position can be staggered and divergent away
from the second leg member along the same wall surface of the
hollow cartridge platform housing to provide unrestricted body
fluid flow in and out of the hollow cartridge platform housing
insert assembly.
In accordance with further embodiments of the present invention,
the hollow cartridge platform housing further includes an internal
flow path, channel or passageway disposed into the cartridge
tubular cartridge insert or along a portion of the sealing surface
of the cartridge insert, for the purpose of providing body fluid
communication from a first hollow leg member proximal port opening
and to a second hollow leg member proximal port opening, when the
first and second sealing surface port openings and internal flow
path of the cartridge insert come into alignment at an intended
fixed position to complete a fluid circuit within the hollow
cartridge platform housing. The internal flow path, channel, or
passageway in the tubular cartridge insert completes a circuit
between the first and second port openings disposed within a
portion of the sealing surface of the tubular cartridge insert, and
the first and second hollow leg member proximal port openings
located in the inner wall surface of the hollow cartridge platform
housing. The tubular cartridge insert with the body fluid
communicating internal flow path, channel, or passageway disposed
into the sealing surface or made part of the sealing surface, can
further include at least one external passageway or lumen that
communicates with an external port opening on the surface of the
internal flow path and communicates with an external port opening
located on one non-sealable external surface of the tubular
cartridge insert. The external passageway or lumen is suitable for
introducing, removing or re-circulating body fluid or other
bioactive fluid or injectable substance. There can additionally be
one or more external passageways or lumens extending from and or
communicating with the cartridge insert internal flow path,
channel, or passageway, to one or more external port openings
located on an external non-sealable surface of the cartridge
insert. Multiple external fluid communicating passageways, lumens
can also communicate with two or more external non-sealable
surfaces of the cartridge insert.
In accordance with further embodiments of the present invention,
the body fluid cartridge exchange platform device further includes
an internal flow path, channel, or passageway disposed along the
sealable surface of the tubular exchange cartridge insert for the
purpose of providing unrestricted body fluid flow from the first
hollow leg member communicating with an organ communicating to the
second hollow leg member communicating with a second organ. The
body fluid channel completes a flow path between a first passageway
opening and a second passageway opening through the first and
second port openings within the sealable surface of the hollow
cartridge platform housing. The tubular exchange cartridge insert
with a body fluid communicating channel along its sealable surface
can further include at least one external passage or lumen that
communicates from a port opening along the surface of the body
fluid channel and out to a port opening located on at least one
non-sealable external surface of the tubular exchange cartridge
insert. The external passage lumen is suitable for introducing or
removing body fluid or another bioactive substance. There can
additionally be one or more external passageways or lumens in
communication with the body fluid channel and to one or more port
openings located on the same non-sealable external surface of the
tubular exchange cartridge insert. Such external passageways or
lumens can also exit out to two or more non-sealable surfaces of
the tubular exchange cartridge insert. The tubular exchange
cartridge insert can further include a first open body fluid
channel port and a second open body fluid channel port at opposite
ends of the channel. The distance between the first channel port
and a first end of the tubular exchange cartridge insert is
greater, in accordance with the one embodiment of the present
invention, than a diameter of the first channel port. In addition,
the distance between the second channel port and the second end of
the tubular exchange cartridge insert is greater than a diameter of
the second channel port.
The tubular cartridge insert can further include a first sealing
surface port opening and a second sealing surface port opening at
opposite ends of a body fluid communicating internal flow path,
channel, or passageway. The distance between the first sealing
surface port opening and a first external non-sealing surface end
of the tubular cartridge insert in accordance with one embodiment
of the present invention, is greater than the diameter of the first
sealing surface port opening. In addition, the distance between the
second sealing surface port opening and the second non-sealing
surface end of the tubular cartridge insert is greater than a
diameter of the second sealing surface port opening to facilitate
leak-proof movement, displacement or exchange of the tubular
cartridge insert by another cartridge insert.
A portion of the first and second hollow leg members penetrate and
reside within the skin of a patient when the body fluid cartridge
exchange platform device is surgically implanted in accordance with
one embodiment of the present invention. The first and second
hollow leg members further support the raised hollow cartridge
platform housing distally, in a raised condition up and off the
surface of the skin. In accordance with one embodiment of the
present invention, the first passageway and distal port opening of
the first hollow leg member and the second passageway and distal
port opening of the second hollow leg member are both in fluid
communication with the same body fluid organ, or each independent
hollow leg member can be in fluid communication with two distinctly
separate body fluid organs and/or two remotely located similar body
fluid organs of the patient.
In accordance with still further embodiments of the present
invention, the appropriately sized and matched body fluid tubular
cartridge insert and hollow cartridge platform housing have a
generally oval cross-section and uniform sealable contact surface
relative to each other to provide precision cartridge component
surface alignment to the sealable contacting surface of the hollow
cartridge platform housing. It will be further understood that such
a tubular oval shape also provides radial alignment of all sealing
wall surface and sealing surface port openings inside the hollow
cartridge platform housing. The tubular form and oval shape
maintains sealing surface engagement between the tubular cartridge
insert and the hollow cartridge platform housing simultaneous to
preventing cartridge insert misalignment by rotation, for maximum
body fluid communication alignment and patient safety.
In accordance with another example embodiment of the present
invention, a mechanically simplified, externally connectable body
fluid cartridge exchange platform device is provided. The body
fluid cartridge exchange platform device has a hollow tubular
receiving lumen with a first end having an opening. The body fluid
cartridge exchange platform device additionally has a second end
having an opening. Each open end of the tubular receiving lumen
facilitates insertion of a matching tubular cartridge insert that
fits into and sealably engages within the tubular receiving lumen.
Both the first and second platform housing openings additionally
facilitate bi-directional removal of an installed tubular cartridge
insert by direct contact of at least one non-sealable surface of
the tubular cartridge insert, and forceful displacement by a
another interchangeable or replacement tubular cartridge insert's
non-sealable surface.
BRIEF DESCRIPTION OF THE DRAWINGS
The aforementioned features, patient benefits, clinical advantages,
in addition to many other physical and mechanical features and
aspects of the present invention, will become better understood
with regard to the following description and accompanying drawings,
wherein:
FIG. 1 is a diagrammatic illustration of a cartridge exchange
platform device according to one aspect of the present
invention;
FIG. 2 is a diagrammatic illustration of the cartridge exchange
platform device according to a further aspect of the present
invention;
FIG. 3 is a diagrammatic illustration of the cartridge exchange
platform device with one body fluid communicating cartridge
installed within a hollow cartridge platform housing according to
one embodiment of the present invention;
FIG. 4 is a diagrammatic illustration of the device with the
cartridge insert of FIG. 3 in addition to a second or replacement
cartridge insert displacing a first installed cartridge insert by
forwarding direct contact and movement out one open end of the
cartridge platform housing according to one embodiment of the
present invention;
FIGS. 5A, 5B, and 5C are diagrammatic illustrations showing how
hollow leg member port openings couple in alignment with matching
first and second internal flow path port openings of an installed
tubular cartridge insert, and how the port openings for each
component can go into and out of flow path alignment during tubular
cartridge insert movement, displacement, or exchange inside the
hollow cartridge platform housing according one embodiment of the
present invention;
FIG. 6 is a perspective top view illustration of the hollow
cartridge platform housing with two distinct cartridge insert
examples that are bi-directionally insertable, removable, and
interchangeable within the hollow cartridge platform housing
according to one embodiment of the present invention;
FIG. 7 is a perspective bottom view illustration of the body fluid
cartridge exchange platform device displaying first and second
hollow leg members with first and second distal port openings, and
the two different cartridge inserts of FIG. 6 displaying the
respective annular sealing surface port openings on the sealable
surface of each cartridge insert according to one embodiment of the
present invention;
FIG. 8 is a diagrammatic illustration of portions of an implanted
cartridge platform device that reside above or distal to the
patient's dermal skin surface, and portions of the cartridge
platform housing which penetrate and reside below the patient's
skin surface, and a cartridge insert that is connected external to
and in fluid communication with an example life supporting machine,
such as a dialysis blood filtration apparatus, according to one
embodiment of the present invention;
FIGS. 9A, 9B, and 9C are perspective illustrations of one example
of a hollow cartridge platform housing with one or more cartridge
insert tab receiver elements, and two interchangeable cartridge
insert examples with one or more positively locking tab features,
which snap into the hollow cartridge platform housing insert tab
receiver elements after complete cartridge installation within the
hollow cartridge platform housing according to one embodiment of
the present invention; and
FIGS. 10A and 10B are perspective top and bottom view illustrations
of a cartridge insert exchange tool with a closed containment
chamber on one end of the exchange tool to receive, house, and
contain an expressed or removed cartridge insert according to one
aspect of the present invention.
DETAILED DESCRIPTION
An illustrative embodiment of the present invention relates to a
minimally invasive and percutaneous implantable body fluid
cartridge exchange platform device to provide leak-proof body fluid
communication between one or more internal organs and simplified
external medical treatment connection to one or more internal body
fluid organs. One example of a body fluid organ, for purposes of
clarity in describing the invention, is characterized as a blood
vessel herein. Nevertheless, those skilled in the art will
appreciate the present invention may be used with other internal
body fluid organs and the invention is not limited to applications
for use with those organs in fluid communication with blood
vessels.
The device referred to as the body fluid cartridge exchange
platform device includes two or more hollow leg members extending
out from a hollow cartridge platform housing and penetrating
through two or more separate and remotely located percutaneous
wounds or incisions of the patient. Hollow leg members are in fluid
communication with one or more blood vessels of the patient. For
example, a first hollow leg member can be in fluid communication
with an artery and a second hollow leg member can be in fluid
communication with a vein. The use of the two small diameter leg
members to extend downward through two separate small wound
incisions of the skin surface reduces the amount of surgical
disruption and displacement of skin tissue following device
implantation. The use of two small diameter percutaneous leg
members reduces the amount of skin tissue dissection and
inflammation about the device during wound and skin surface healing
when compared to larger skin penetrating port access devices, which
can be more difficult for skin tissue to stabilize with collagen
remodeling tissue following implantation. In addition, utilizing
two or more small diameter percutaneous leg members rather than one
large skin protruding device, provides more natural movement of the
patient's skin around portions of the leg members and the raised
hollow cartridge platform housing following wound healing. The use
of two or more, small diameter hollow leg members instead of one
large skin protruding main body housing also significantly reduces
the amount of foreign body material and mass, as well as device
surface area that can reside in direct physical contact with
surgical wound tissue, thus significantly reducing the size and
scope of tissue dissection required for implantation. The reduction
in the wound size and scope of wound dissection significantly
improves the rate and completeness of wound healing, significantly
improves the overall strength and flexibility of the healed skin
tissue due to less scarring about the small diameter leg members of
the cartridge exchange platform device, and reduces wound
complications such as inflammation and infection due to less
material mass. In addition, separation or distancing of each small
diameter leg members' wound incision, one independent incision for
each leg member, reduces the likelihood of infection at a first leg
member location from spreading or migrating to the second leg
member location, thus improving the patient's treatment options for
better wound healing outcomes.
The hollow leg members support the cartridge platform housing and
first and second housing openings up, off, and away from direct
contact with the topical surface of the patient's skin. This raised
cartridge platform housing arrangement also creates a boundary of
healthy skin between the two leg members and underneath the
cartridge platform housing to help protect the wound incisions and
make the topical area under the cartridge platform housing
accessible for daily hygiene care. By allowing all externally
cleanable surfaces above, under, and around the platform housing,
including those portions of the leg members that do not come into
direct contact with the patient's skin during normal physical
activity, daily hygiene and skin care can easily be accomplished by
washing and swabbing in and around all externally cleanable
surfaces of the cartridge platform device. Raising all cartridge
insert contact surfaces, cartridge platform housing openings,
cleanable surfaces, and internal tubular sealing surfaces distal to
the patient's skin, further prevent contamination of the cartridge
insert during cartridge exchange. Such a cartridge platform device
also significantly reduces the risk and likelihood of any body
fluid communicating internal flow path, channel, or passageway from
becoming contaminated by direct or physical contact with the
patient's skin during use. The generally horizontal orientation of
the cartridge platform housing and the first and second tubular
platform housing openings being raised up and off the surface of
the skin in a generally horizontal orientation to the skin surface,
together with the use of the sterile cartridge platform exchange
tool, provides a contaminant free, cartridge insert exchange or
change-out technique. The raised cartridge platform arrangement of
the implanted device keeps all internal body fluid communicating
flow paths and all interior sealable wall surfaces of the cartridge
platform device free from direct contact with the sometimes
infected or contaminated skin surface. The body fluid cartridge
exchange platform device significantly reduces the likelihood of
circulating body fluid from becoming contaminated by direct
exposure to topical skin bacteria during cartridge exchange, and
further limits the patient's exposure to infection caused from
internal body fluid contact with topical skin sourced bacteria,
e.g. Staphylococcus bacteria including Staph. Aureus and Staph.
Epidermis.
In accordance with one embodiment of the present invention, the
body fluid cartridge exchange platform device includes a tubular
housing with an interior sealing surface having two openings, one
at each end. The existence of the two horizontally oriented tubular
openings enables a patient, family member, or healthcare worker, to
bi-directionally insert, exchange and or remove the tubular
cartridge inserts. The tubular and generally oval shaped cartridge
inserts can be constructed of one or more assembled elements or
parts to form one leak-proof tubular cartridge unit, or formed as a
multi-cartridge, leak-proof assembly unit. The cartridge insert can
easily be inserted, displaced, and removed out through either open
end of the cartridge platform housing by forward directed contact
and displacement from insertion of a second cartridge insert and
use of a sterile cartridge exchange tool.
FIGS. 1 through 10B, wherein like parts are designated by like
reference numerals throughout, illustrate an example embodiment of
a body fluid cartridge exchange platform device according to the
present invention. Although the present invention will be described
with reference to the example embodiment illustrated in the
figures, it should be understood that many alternative forms can
embody the present invention. One of ordinary skill in the art will
additionally appreciate different ways to alter the mechanical
sealing surfaces, geometry, and biological interfacing parameters
of the embodiments disclosed, such as the size, shape,
biocompatibility, mechanical locking and release mechanisms,
internal flow path orientation, external attachment and connection
means, sealable wall surface engagement, mechanical construction
and assembly, electromechanical body fluid sensor means, or type of
materials and or construction methods used to manufacture and
package such a device, in a manner still in keeping with the spirit
and scope of the present invention.
FIG. 1 illustrates a diagrammatic side view of a body fluid
cartridge exchange platform housing, (platform housing 12). A body
fluid cartridge exchange platform device 10 tubular and generally
oval shaped platform housing 12. The platform housing 12 is
substantially hollow, and as shown in later illustrations, has a
generally oval cross-section, although other cross-section profiles
are possible. There is a first small diameter hollow leg member 14
extending out from the platform housing 12 in a first direction,
and a second small diameter hollow leg member 18 extending out from
the platform housing 12 in an angled and divergent direction
relative to the first leg member 14. The first leg member 14 and
the second leg memberl8 angle away from each other. The angles of
each leg member 14 and 18 ease the surgical installation or
implantation of a portion of the leg members 14 and 18, which
penetrate through and reside within two small and separate wound
incisions. The divergent angles of the hollow leg members 14 and 18
and their corresponding internal flow path, channel, and/or fluid
passageway 16 and 20 reduce the occurrence of flow restrictive
corners in the transition flow path, channel, or passageway located
inside an aligned cartridge insert within the cartridge platform
housing 12.
Taking the example of body fluid flow in a patient's blood vessels,
each vessel runs generally parallel along the straight line
direction of, e.g., the patients arm, leg, torso, or internal body
cavity. It is desirable when body fluid is to be removed and or
re-circulated back into the patient's arm for the body fluid within
the cartridge platform device to follow a generally straight line
flow path that angles up and away from the surface of the arm, then
returns back into the patient at the same generally straight line
flow path and divergent angle. Thus, the angle of the platform leg
members 14 and 18 directs the flow of blood away in a generally
straight line flow path from the body fluid organs or blood
vessels, and returns the blood to back to the blood vessels in the
same generally straight line direction, without using sharp angles
that could cause undue fluid turbulence and fluid damage. Sharp,
hard edge angles can adversely affect the natural flow dynamics of
the blood, and damage fragile blood cell components, in addition to
inducing chemical activation of certain blood containing components
such as platelets, and circulating fibrinogen.
Each leg member 14 and 18 can take the form of a separate component
fixedly coupled to the platform housing 12 by conventional means,
such as adhesive, welding, thread connections, or equivalent
leak-proof coupling means. Alternatively, the platform housing 12
can be formed with the leg members 14 and 18 included, forming the
platform housing 12 and the leg members 14 and 18 as a single
monolithic housing. In addition there can be a number of leg
members other than two, such as a single skin penetrating leg
member that bifurcates into two body fluid flow paths below the
surface of the skin, or a plurality of leg members greater than two
that percutaneously enter through the skin independently. The
ultimate clinical purpose set for the particular cartridge exchange
platform device 10 will dictate the actual number of housing leg
members required to carry out the intended clinical purpose and or
body fluid communication requirement. If, for example, four blood
vessels are to be connected to the cartridge exchange platform
device 10, the device 10 may require four leg members.
The first leg member 14 and the second leg member 18 each include
one or more annular ridges, depressions, diverging grooves, or
faceted wall surfaces 22 disposed on a portion of each leg member
14 and 18 external wall surface. The external annular ridges 22
facilitate one method to maximize the mechanical connection
strength of the first and second leg members to either natural
tissue or to medical grade tubular materials such as those
synthetic and biologic materials commonly used in forming
leak-proof body fluid connections with blood vessels or other body
fluid communicating organs within a patient. For example, the leg
member ridges 22 enable a synthetic or biological vascular graft
material, and/or a piece of medical grade tubing to grasp securely
onto the annular ridges of each leg member 14 and 18, to hinder
undesirable slippage, removal, or disconnection from the platform
housing leg members 14 and 18. The biological vascular graft
material can take the form of a microporous healable cuff (e.g.,
first and second organ communicating means 84 and 86 shown in FIG.
8). The microporous nature of such a cuff enables cell penetration
to further stabilize a coalescing of the cuff with body tissue to
hold the body fluid cartridge exchange platform device 10 in
place.
The platform housing 12 additionally includes a first opening 28 at
a first end of the platform housing 12 and a second opening 30 at a
second end of the platform housing 12. The first opening 28 and the
second opening 30 provide bi-directional access into the hollow
tubular interior and sealably engaging wall surfaces of the
platform housing 12. The platform housing 12 interior wall surface
extends in a generally straight line along a length between the
first opening 28 and the second opening 30 as illustrated. However,
the platform housing 12 can also follow a slightly arcuate path
between the first opening 28 and the second opening 30 if desired,
so long as any cartridge insert that is made to match and fit
within the hollow tubular wall surface portion of the platform
housing 12 maintains a leak-proof seal with a portion of the
platform housing's arcuate shape, and/or flexes uniformly to
maintain a leak-proof seal with a portion of the same generally
arcuate tubular platform housing shape.
The platform housing 12 and the first and second leg members 14 and
18 can be made from a single material, or from a blend of two or
more similar materials, or be constructed from two or more
distinctly different materials, including the use of several layers
or coatings of similar or dissimilar formable materials, such as
biocompatible Class IV, or equivalent medical grade, and/or body
fluid compatible plastics, e.g. PEEK, PET, Acrylic Co-Polymers,
PTFE, PVC, Synthetic Elastomers and or Polycarbonate.
The dimensions of the example embodiment are determined primarily
by the value of the internal diameter of the internal leg members
14 and 18. More specifically, the internal diameter of the internal
leg members 14 and 18 requires a minimum internal diameter passage
for the path connecting the two internal leg members 14 and 18 as
later described herein. The minimum size for the path subsequently
dictates the overall size of the body fluid cartridge exchange
platform device 10. For example, if the internal diameter of the
internal leg members 14 and 18 was between 2 mm and 4 mm, the path
would be smaller than if the internal diameter was between 3 mm and
5 mm. Thus a relatively smaller body fluid cartridge exchange
platform device 10 would be required. These are example
measurements that are by no means intended to limit the dimensions
of the present invention. One of ordinary skill in the art will
appreciate that the particular purpose for which the invention is
used will dictate the size of the internal leg members 14 and 18,
and thus the overall size of the body fluid cartridge exchange
platform device 10.
These internal platform housing 12 dimensions and internal leg
member 14 and 18 dimension ratios illustrate a few examples of an
appropriate sized and small diameter leg member cartridge exchange
platform device 10. However, the dimensional platform housing 12
sizes and leg member 14 and 18 dimensional size ratios can vary, as
understood by one of ordinary skill in the art, as different
implant locations, specific anatomical conditions, clinical purpose
and flow requirements, cartridge insertion requirements, and or
sealing surface requirements can determine the actual dimensional
size requirements for each clinical purpose and the method of use
for the body fluid cartridge exchange platform device 10.
FIG. 2 illustrates an example of the platform housing 12 with two
independent tubular leg members 14 and 18, and the internal fluid
passageways 16 and 20 located inside the two hollow leg members 14
and 18, along with first and second leg member distal port openings
40 and 42, and first and second leg member proximal port openings
24 and 26 of FIG. 1 in phantom form. The platform housing 12
includes the first leg member 14 and the second leg member 18
attached thereto. The platform housing 12 further includes the
first leg member proximal port opening 24 in the interior sealing
wall surface of the platform housing 12. The first leg member
proximal port opening 24 provides body fluid communication to an
interior wall surface portion of the hollow platform housing 12.
The platform housing 12 also includes the second leg member
proximal port opening 26 in the interior wall surface of the
platform housing 12. The second leg member proximal port opening 26
also provides fluid communication to an interior wall surface
portion of the platform housing 12. The second proximal port
opening 26 can be located diagonally offset from the first proximal
port opening 24 on the same interior wall surface of the platform
housing 12, or placed at a different radial location from the first
proximal port opening 24 of the same interior wall surface of the
platform housing 12, and/or can be located anywhere along the
interior sealing wall surface of the platform housing 12 so as to
provide cartridge insert sealing surface engagement inside the
tubular platform housing during cartridge insert movement, exchange
and/or displacement by forward directed contact and movement from a
second cartridge insert, which will be disclosed further herein
(see FIGS. 5A, 5B, and 5C).
The first leg member 14 includes the first internal passageway 16,
and the second leg member 18 includes the second internal
passageway 20. The first internal passageway 16 extends from the
first leg member proximal port opening 24 to the first leg member
distal port opening 40. The second internal passageway 20 extends
from the second leg member proximal port opening 26 to the second
leg member distal port opening 42. The first and second leg member
distal port openings 40 and 42 provide fluid communication into and
out from the cartridge exchange platform device 10, from one or
more body fluid organs of the patient, depending on the particular
clinical purpose and requirement for the body fluid cartridge
exchange platform device 10.
The platform housing 12 additionally includes a first positive
locking tab receiver 58 disposed in one interior and tubular
sealing wall surface. For selected clinical applications and uses,
more than one positive locking tab receiver 58 may be required.
Therefore a second positive locking tab receiver 60 can be disposed
into the interior sealing wall surface of the platform housing 12,
at a second interior sealing surface location. In accordance with
one embodiment of the present invention, two locking tab receivers
58 and 60 can be located independently and at opposite ends of the
platform housing 12 to each other, and/or located at opposite sides
of the platform housing 12 to each other, or further can be located
side by side to each other in any orientation within the same
radial orientation of tubular sealing wall surface of the platform
housing 12. The first receiver 58 and the second receiver 60, as
illustrated in the embodiment shown, are in the form of rectilinear
apertures through the wall of the platform housing 12. The first
and second receivers 58 and 60 accommodate a portion of the
cartridge insert locking tab 62, which extends out from and beyond
the radial tubular sealing surface of a cartridge insert 32 or 44,
and the tubular cartridge insert reaches its intended fixed
destination location within the platform housing 12. Further
descriptions of the cartridge insert locking tab mechanism 62, will
be discussed later herein.
One of ordinary skill in the art will appreciate that the location,
shape, depth, size and orientation of the aperture forming the
first and second locking tab receivers 58 and 60 may vary,
depending upon the clinical purpose, flow performance, dimensional
size requirements of the cartridge insert and sealing surface
requirements, and patient safety considerations for the body fluid
cartridge exchange platform device 10. The shape of each receiver
58 and 60 can be a hole, depression, or ridge disposed into and/or
through the wall surface of the platform housing 12 and can be made
in a number of different configurations or geometric shapes
including a circle, square, rectangle, crescent, or triangle.
Further, each receiver 58 and 60 can be uniform, non-uniform,
irregular, or formed into a desirable shape suitable for positive
locking, containing, or anchoring the cartridge insert locking tab
62 into the wall of the platform housing 12. The receiver 58 and 60
must, however, be appropriately sized and dimensioned to receive,
accommodate, and fix the radially extending locking tab 62 found on
each of the tubular cartridge inserts 32 and 44, as will be
discussed in further detail later herein.
FIG. 3 provides visual detail of the fixed position of a primary
body fluid cartridge insert (primary cartridge insert 32) contained
entirely within the platform housing 12. The primary cartridge
insert 32 contains an internal flow path 34 for body fluid or blood
to enter, flow through, and exit, through the internal flow path 34
of the primary cartridge insert 32 when installed inside the
cartridge exchange platform device 10. The installed primary
cartridge insert 32 receives body fluid from the first leg member
14 and first internal passageway 16, and through the first leg
member proximal port opening 24 of the platform housing 12. The
internal flow path 34 inside the cartridge insert 32 completes a
fluid circuit between the first and second leg member proximal port
openings 24 and 26 of the cartridge exchange platform device 10 by
coupling first and second sealing surface port openings 36 and 38
into alignment with the first and second leg member proximal port
openings 24 and 26. The completion of the body fluid flow circuit
between the first and second leg member internal passageways 16 and
20 of the cartridge exchange platform device 10, made possible by
the internal flow path 34 of the primary cartridge insert 32, is
required when a patient does not require the cartridge exchange
platform device 10 to be connected to an external medical apparatus
for treatment. The primary cartridge insert 32 is indicated for use
when the patient does not require external connection or attachment
to an external medical apparatus, and only needs circulating body
fluid to flow continuously and unhindered through the internal flow
path 34 and the first and second leg member internal passageways 16
and 20 of the cartridge exchange platform device 10. This
arrangement allows the patient to perform their normal daily
activities.
It should be noted that all internal body fluid flow path port
openings, sealing surface port openings, and port opening alignment
locations, including those of the first and second leg member
proximal port openings 24 and 26 of the platform housing 12, are to
couple and match the annular shape and size of those sealing
surface port openings 36 and 38 of the cartridge insert 32, which
complete the internal flow path 34 fluid circuit between the first
and second leg member internal passageways 16 and 20, as
illustrated in FIGS. 3 and 5A. The illustrations of FIGS. 5A, 5B,
and 5C represent one example of many possible cartridge insert 32
sealing surface port opening alignment configurations that can be
made to maximize flow performance, ensure manufacturability, and
attain continuous body fluid utilization through the properly
aligned cartridge insert 32 and sealing surface port openings 36
and 38 when coupled into alignment with those of the first and
second leg member proximal port openings 24 and 26, located in the
interior wall surface of the platform housing 12. FIG. 5B depicts
the cartridge insert 32 being installed by forward directed
movement from left to right, and through a first open end 28 of the
platform housing 12. FIG. 5C shows the same cartridge insert 32
being displaced out through the second open end 30 of the platform
housing 12 as shown in FIG. 5B, with the cartridge insert sealing
surface port openings 36 and 38 going out from alignment with the
first and second leg member proximal port openings of the platform
housing 12 when a first cartridge insert 32 needed to be exchanged
or removed out from the platform housing 12 by forward directed
movement and contact from a second cartridge insert within the same
platform housing 12.
The first leg member 14 includes the first hollow internal
passageway 16 that provides fluid communication between the first
leg member distal port opening 40, and the first leg member
proximal port opening 24 located in the interior wall surface of
the platform housing 12. The second hollow internal passageway 20
of the second leg member 18, and the second leg member proximal
port opening 26 located in the interior wall surface of the
platform housing 12 maintain fluid communication with the second
leg member distal port opening 42. The primary cartridge or
maintenance insert 32 includes the first sealable surface port
opening 36 and a second sealable surface port opening 38, which
communicate via the internal flow path, channel, or passageway 34
located internal to the cartridge insert 32 or made part of the
outer sealing surface as an open channel. The first leg member
proximal-port opening 24 aligns with the first cartridge insert
sealing surface port opening 36. The second leg member proximal
port opening 26 also aligns with the second cartridge insert
sealing surface port opening 38 to complete the internal flow path
circuit between the first leg member internal passageway 16, the
second leg member internal passageway 20, and the primary cartridge
insert 32 internal flow path, channel, or passageway 34.
A locking tab 62 extends in a generally outward and radial
direction from the tubular form cartridge insert 32 into the first
locking tab receiver 58 in the wall of the platform housing 12. The
locking tab 62 disposes into the first receiver 58, thus causing
the cartridge insert 32 to stop and become fixed in position within
the platform housing 12. The locking tab 62 extends outward and
generally beyond the outer radial sealing surface of the primary
cartridge insert 32 to snap into place within the first receiver 58
when the primary cartridge insert 32 reaches its intended fixed
destination within the platform housing 12. The locking tab 62 does
not generally align the primary cartridge 32 within the platform
housing 12, it merely prevents the installed primary cartridge
insert 32 from further movement within the platform housing 12 once
the installed primary insert reaches its intended fixed
destination. The generally oval cross-sectional shape together with
the tubular containment function of the platform housing 12
provides the radial alignment means for the first and second leg
member proximal port openings 24 and 26 of the platform housing 12
with those sealing surface port openings 36 and 38 of the primary
cartridge insert 32. The locking tab 62 serves the intended purpose
to only stop, lock, or anchor the primary cartridge 32 at an
intended fixed location when the primary cartridge 32 is properly
disposed within the platform housing 12. The locking tab 62 is not
part of any mechanical guidance or sealing surface feature within
the tubular cartridge platform housing 12, nor does the locking tab
62 function as or perform a sealing surface purpose. Further, the
locking tab 62 of the cartridge insert 32 is not part of any
cartridge insert 32 installation guidance means, holding means, or
holding element for the purposes of attaining sealing surface
engagement between the cartridge insert 32 sealing surface 32A and
the interior sealing surface 12A of the platform housing 12.
The cross-sectional area of the first internal passageway 16 of the
first leg member 14 is less than the cross-sectional area of the
second internal passageway 20 of the second leg member 18 in
accordance with one embodiment of the present invention. The
cross-sectional area of the first and second leg members 14 and 18
can vary, depending on the particular purpose, clinical
application, anatomical location, fluid flow performance, or
external medical treatment required of the cartridge exchange
platform device 10.
The cartridge exchange platform device 10 illustrated in FIG. 3 is
designed for use with any body fluid containing organ, including
for use with a patient's arterial and venous blood vessels. The
nominal blood fluid pressure, volume, and flow velocity through an
artery is greater than the blood fluid pressure, volume, and flow
velocity through a vein. The dimensional size ratio of the platform
housing 12 and the first and second leg members 14 and 18, in
addition to all internal fluid communicating cross-sectional areas
of the first and second leg member internal passageways 16 and 20,
can vary in diameter to each other to accommodate differences in
fluid pressure and flow velocity gradients from a first fluid
communicating organ to a second fluid communicating organ. For
example, there exists a significant gradient difference between the
nominal blood pressure, flow volume, and velocity of an artery, to
that of the nominal blood pressure, flow volume, and velocity of a
vein.
When the cartridge exchange platform device 10 is used as a means
to provide an arterial to venous blood flow direction, more
commonly referred in the healthcare industry as an AV shunt, or for
the purpose of establishing a flow direction from a first higher
pressure environment of the arterial blood system to a second lower
pressure environment of the venous blood system, there can be a
significant blood pressure gradient difference from the first leg
member distal port opening 40 and first internal passageway 16, to
the second leg member internal passageway 20 and second leg member
distal port opening 42. One embodiment of the cartridge exchange
platform device 10 includes a provision to keep the fluid pressure
and flow rate exiting the second leg member distal port openings 42
located on the second leg member 18 generally less than the fluid
pressure and flow rate entering the first leg member distal port
opening 40. Likewise it can be desirable to make the fluid pressure
and flow rate of the second leg member internal passageway 20
generally less than the fluid pressure and flow rate of the first
leg member internal passageway 16. For this particular clinical
purpose, the fluid pressure and flow rate gradient can be modulated
by making the first leg member distal port opening 40 and first leg
member internal passageway of the cartridge exchange platform
device 10 smaller in cross-sectional area than the second leg
member distal port opening 42 and first leg member internal
passageway 20, and by making the first sealing surface port opening
36 on one end of the internal flow path 34 of the cartridge insert
32 smaller than the second sealing surface port opening 38 thereby
allowing fluid to flow in a direction beginning from a first higher
pressure and flow rate (e.g. higher blood pressure value) to a
generally different or lower second pressure and flow rate (e.g.
lower blood pressure value) as the fluid or blood flows through the
cartridge exchange platform device 10.
For another clinical requirement, it may be desirable to reverse
the flow direction and pressure gradient purpose of the body fluid
cartridge exchange platform device 10, as previously described
above, by increasing the forward directed flow rate and pressure
out from the second leg member distal port opening 40 and second
leg member internal flow path 16. For example, modulation of the
first lower fluid pressure and flow rate to a second higher
pressure and flow rate is accomplished by use of dimensionally
reducing cross-sectional area flow path sections, or by use of
multiple, progressively smaller flow path portions along the entire
length of the forward directed flow path within the cartridge
exchange platform device 10. Forward directed fluid flow can
further be modulated from a first low fluid pressure value to a
second higher fluid pressure value within the cartridge exchange
platform device 10 by the use of a larger first leg member distal
port opening 42, and larger first leg member internal passageway
20, than the smaller second leg member internal passageway 16, and
smaller second leg member distal port opening 40.
Whether or not body fluid or blood traverses through the primary
cartridge insert 32 and internal flow path 34 unhindered, or the
body fluid or blood circulates out from the secondary cartridge
insert 44 to an external fluid communicating medical apparatus
through a first external port opening 50 in communication with an
external flow path 51 and flows back again into the same cartridge
insert 44 through a second external flow path 53 and through the
second external port opening 48, the fluid pressure and flow rate
within the cartridge exchange platform device 10 can be modulated,
reduced, or increased by making the first internal passageway 16
cross-section area of the first leg member 14 different than the
second internal passageway 20 cross-section area of the second leg
member 18. For example, a larger second internal passageway 20
cross-sectional area than a first smaller internal passageway 16
causes the fluid pressure and flow gradient to lower from a first
higher entering pressure and flow rate value as the body fluid
traverses through the cartridge exchange platform device 10.
Therefore, body fluid or blood pressure and flow rate through a
cartridge exchange platform device 10 can be altered, changed,
modulated, or decreased from a first higher entering pressure and
flow rate value by making the second leg member internal passageway
20 larger or sufficiently different in cross-sectional area to the
first leg member internal passageway 16. Such a fluid pressure and
flow modulating feature is required for most arterial to venous
body fluid communicating uses with the cartridge exchange platform
device 10, where it would be desirable to reduce the higher
arterial blood fluid pressure and flow rate value, down to a second
more physiologic and generally lower fluid pressure and flow rate
value, commensurate with that of the patient's ability to
accommodate an elevated venous pressure and flow rate value that is
less than the first higher arterial pressure and flow rate. For
such clinical applications, purpose, and use of the cartridge
exchange platform device 10, the fluid pressure and flow rate
modulation feature helps minimize the damaging effects to
circulating blood cells, blood platelets and or endothelial cell
lined vein surfaces from exposure to nominal arterial blood
pressure and flow rates encountered with more traditional arterial
to venous body fluid connection means.
All tubular sealing surface engaging cartridge inserts of the
cartridge exchange platform device 10, include one or more body
fluid communicating internal flow paths, channels, or passageways
34 whose principal function is to complete a body fluid
communicating circuit between the first leg member 14 and its
internal passageway 16, through a portion of the platform housing
12, and through the second leg member 18 and its internal
passageway 20. The cartridge insert internal flow path is generally
tubular and can be further sized, dimensioned, or formed to either
a conical or tapered shape, made generally smooth surfaced
throughout, or made from several shorter faceted surfaces without
sharp edges, and/or made coated, covered, or lined with medically
purposeful bioactive substances (eg. such as an anticoagulant,
antiseptic, gene therapy medication, anti-inflammatory medication,
or a hydrophilic fluid surface treatment) to further reduce
internal flow path fluid pressure resistance and flow rate
resistance, internal flow path wall surface shear force, or to
increase wall surface lubricity along all or a portion of the
internal flow path or passageway 34, or to reduce the likelihood of
circulating body fluid components and or blood cell components from
being activated by direct surface contact with any portion of the
internal flow path, channel or passageway 34 inside the primary
cartridge insert 32, and including any portion of the external
fluid communicating flow paths, channels or passageways 51 and 53
of the secondary cartridge insert 44. The coatings can be placed in
all or part of the areas exposed to body fluids.
The generally tubular and arcuate internal flow path and flow
surface characteristics of the internal flow path, channel, or
passageway 34 located within the cartridge insert 32 and 44 carry
throughout a wide variety of clinical purpose and indications for
use, and further carry throughout the many possible tubular
cartridge insert styles, types, and/or sealing surface
configurations for use with the body fluid cartridge exchange
platform device 10. The internal flow path, channel, or passageway
34 for any primary cartridge insert 32, including any secondary
cartridge inserts 44 that employ an internal flow path, channel, or
passageway 34 diagramed in FIG. 6, makes a slow, generally arcuate
turn between the first sealing surface port opening 36 and the
second sealing surface port opening 38 to maintain body fluid flow
between the first leg member proximal port opening 24 and the first
internal passageway 16 of the cartridge exchange platform device
10, to the second leg member proximal port opening 26 and second
internal passageway 20. Sharp comers of less than 90 degrees or
narrow cross-sectional area flow paths, channels or passageways are
known by those of ordinary skill in the art to restrict or impede
body fluid and blood flow, due to several different physical
limiting flow conditions and or chemical variables that can coexist
in the natural body fluid environment, e.g. body fluid viscosity,
cellular component percentage of fluid volume, hematocrit,
percentage of hydration and water content of the fluid contents,
degree of systemic medication if applicable, coagulation, and or
varying levels of body fluid toxicity as found in patients with
ESRD.
The generally smooth, arcuate and angled turn of 90 degrees or
greater within the internal flow path 34 of the cartridge insert 32
and 44 can be either continuous from the first annular sealing
surface port opening 36 to the second annular sealing surface port
opening 38, or can be made to function similar to an arcuate or
angled turn by use of many smaller, non-continuous angles in
sequence with many short, flat, or faceted surfaces, which when
used as a whole contribute and function as a continuous arcuate
internal flow path circuit between the first leg member 14 and
internal passageway 16 and the second leg member 18 and internal
passageway 20 within the cartridge exchange platform device 10.
Such a generally smooth, arcuate radius and angled turn of 90
degrees or greater internal flow path function, plays a role in
maintaining continuous body fluid and blood flow by minimizing body
fluid stasis, pooling, and shear along the internal flow path 34 of
the cartridge platform inserts 32 and 44. In addition, the lack of
sharp, hard edge turns substantially prevents the occurrence of
blood cells and or blood platelets from being damaged, activated or
forced into aggregate bundle formation from direct contact with
irregular shaped surfaces and sharp angled turns within the
internal flow path, channel, or passageway 34.
The coupling means of the first and second leg members 14 and 18 to
the platform housing 12 of the cartridge exchange platform device
10 has a generally smooth and aligned transition, such that the
body fluid communicating internal flow path of the platform housing
12 and first and second leg member respective internal flow paths
16 and 20 do not have sharp, hard edged surfaces when coupled in
alignment with the cartridge insert 32 and 44. The smooth first leg
member internal passageway 16 coupling means to the platform
housing 12 and the cartridge insert 32 or 44, and the smooth second
leg member internal passageway 20 coupling means at different
location to the same platform housing 12 wall surface and cartridge
insert 32 or 44, further reduces the likelihood of bacterial
colonization and bio-film formation from harboring into,
aggregating on and anchoring to, uneven internal coupling surfaces
in and around the tubular internal flow path portions of the
platform housing 12, internal passageway portions 16 and 20 of the
first and second leg members 14 and 18, and cartridge insert
sealing surface port openings 36 and 38.
FIG. 4 illustrates the cartridge exchange platform device 10 with
the primary cartridge insert 32 in a partially moved, displaced and
un-fixed condition away from its intended fixed destination
position within the platform housing 12. To exchange or remove a
fixed or locked position cartridge insert 32 and 44 out from the
inside of the platform housing 12, or any body fluid communicating
cartridge insert installed in its intended operable and fixed
position within the housing and having a locking tab 62, a user
first must depress or push the locking tab 62 of the indwelling
cartridge insert to be exchanged or removed, sufficiently inward
through the first receiver 58 to release the locking tab from
containment within the first receiver 58 and to subsequently allow
the movement or displacement of the cartridge insert 32 or 44, by
forcibly moving the now released cartridge insert out through one
open end 28 or 30, of the platform housing 12. Once the locking tab
62 clears the containment means of the receiver 58 located in the
wall of the platform housing 12, followed by simultaneous forward
directed movement of the cartridge insert 32 by direct contact and
displacement by another cartridge insert 44 away from its former
fixed location within the platform housing 12, allows the locking
tab 62 to remain in a generally recessed position inside the
interior wall surface of the platform housing 12, until after the
cartridge insert being exchanged, removed, or displaced by another
or second cartridge insert 32 or 44, is completely expressed from
the cartridge exchange platform device 10. It should be known that
the cartridges 32 and 44 (see FIG. 6) illustrated herein are shown
being inserted and removed from both the first platform housing
opening 28 and the second platform housing opening 30 of the
tubular cartridge exchange platform device 10. The cartridge insert
examples illustrated in FIG. 6, and other body fluid communicating
cartridge inserts not illustrated and made to work with the body
fluid cartridge exchange platform device 10 in accordance with the
present invention, can also be exchanged, inserted, installed into
a fixed and operable position, and removed from the platform
housing 12 using the same two annular platform housing openings 28
or 30 interchangeably.
As illustrated in FIG. 4, a second tubular cartridge insert 64 is
shown partially entered into the platform housing 12 through the
first platform housing tubular opening 28, with the first primary
cartridge insert 32 being partially displaced out through the
second platform housing tubular opening 30 by the user's forward
directed movement of the second cartridge insert 64. To make ready
the cartridge exchange platform device 10 prior to forward directed
insertion of a new or second tubular cartridge insert 64 in through
the first platform housing tubular opening 28, the user must first
depress and hold the locking tab 62 of the first installed primary
cartridge insert 32, so as to sufficiently release it from the
locking tab receiver 58 in the wall of the platform housing 12 to
allow forward directed movement of the primary cartridge insert
away from its former fixed and locked position. To make ready the
installation of the second cartridge insert 64, the locking tab 62
of the second tubular cartridge insert 64 must be recessed and held
in a contained recessed condition prior to or simultaneous to the
user's forward directed movement and insertion of the second
cartridge insert 64 in through the first platform housing opening
28 and subsequent placement inside the tubular form platform
housing 12. As part of any cartridge insert installation technique
with a radially extending locking tab 62, the locking tab 62 must
be held or sufficiently contained in an depressed condition to
allow a portion of the locking tab 62 to enter into and make
contact with the interior wall surface of the platform housing 12.
By continued forward directed movement of the second tubular
cartridge insert 64 within the platform housing 12 by the user, the
un-fixed or released first primary cartridge insert 32 can then be
expressed out through the cartridge platform housing second opening
30, as it is pushed outward by the user's continued forward
directed movement of the second cartridge insert 64, and until the
second cartridge insert reaches its intended fixed or locked
destination within the cartridge exchange platform device 10.
Forward directed movement, insertion and removal of the cartridge
inserts 32 and 44, in or out of the platform housing 12 is possible
through either of the first and second platform housing openings 28
and 30. The cartridge insert 64 of this illustration is
representative of any form of a tubular and locking tab cartridge
insert that is made for bi-directional and forward directed
insertion means by a user within a body fluid cartridge exchange
platform device 10. Further, the cartridge insert 64 can be another
alternative purposeful cartridge insert, such as another primary
cartridge insert 32 or a secondary cartridge insert 44 with
external body fluid communicating means out through one external
cartridge insert non-sealing surface. The cartridge insert 32 and
44 and the platform housing 12 can each contain a marking 19 (see
FIG. 4) acting as a direction indicator that indicates the correct
arrangement and alignment for insertion of the insert 32 and 44
into the platform housing 12.
As the primary cartridge insert 32 is pushed forward from its
former fixed and operable body fluid communicating position by
direct contact and forward directed movement of the second
cartridge insert 64 by the user, and moved simultaneously out
through the second tubular platform housing opening 30, the first
annular sealing surface port opening 36 and the second annular
sealing surface 38 are both moved away from body fluid
communication and or annular alignment with the first leg member
proximal port opening 24 and the second leg member annular port
opening 26 of the cartridge exchange platform device 10. In one
embodiment of the invention, the interior wall surface distance
between the first leg member proximal port opening 24 in the
platform housing 12 and the first platform housing opening 28 must
be greater than the diameter of the first internal flow path
sealing surface port opening 36 of the cartridge insert 32.
Likewise, the interior wall surface distance between the second leg
member proximal port opening 26 in the platform housing 12 and the
second platform housing opening 30 must be greater than the
diameter of the second internal flow path sealing surface port
opening 38 of the cartridge insert 32. The ratio of the interior
wall surface distance between the first leg member proximal port
opening 24 and the first platform housing opening 28 relative to
the diameter of the first internal flow path sealing surface port
opening 36 of the cartridge insert 32 must be greater than one.
Likewise, the ratio of the interior wall surface distance between
the second leg member proximal port opening 26 and the second
platform housing opening 30 relative to the diameter of the second
internal flow path sealing surface port opening 38 must also be
greater than one. For example, if the desire is for the wall
distance to be about 5% greater then the port diameter, the ratio
would be greater than one, or 1.05. These two sealing surface
distance ratios prevent body fluid from exiting out from the first
and second leg member internal passageways 16 and 20 of the
platform housing 12 during cartridge insert movement, displacement
or exchange.
These dimensional sealing surface distance requirements also
prevent large boluses of ambient air and/or continuous open air
access from outside of the platform housing 12 from entering into
the patient from either of the first leg member proximal port
opening 24 and into the first leg member internal passageway 16, or
the second leg member proximal port opening 26 and into the second
leg member internal passageway 20 of the first and second leg
members 14 and 18 during cartridge insert 32 and 44 movement by the
user during insertion, exchange, or replacement. This patient
safety feature reduces the likelihood of air and/or airborne
contaminants from entering into body fluid circulation through the
partially open and exposed second sealing surface port opening 38
as the cartridge insert 32 and the second sealing surface port
opening 38 begins to exit and move outside of the platform housing
12 and the first sealing surface port opening 36 remains engaged to
and inside the platform housing wall surface. The proper sealing
surface distance prevents air from entering back into either the
first and second leg member proximal port openings 24 and 26, and
or from entering back into either the first and second leg member
internal passageways 16 and 20 during cartridge insert 32 and 44
movement into or out from the cartridge exchange platform device
10. The sealing surface distance configuration of the cartridge
exchange platform device 10 provides another patient safety feature
as it also provides leak-proof exchange of the cartridge inserts 32
and 44 by not allowing body fluid or blood to escape out through or
between the first or second leg member proximal port openings, or
allow continuous flow of body fluid or blood to escape out from a
partially displaced or partially exposed cartridge insert 32 with a
portion of the internal flow path and one sealing surface port
opening, either 36 or 38, partially exposed outside of the platform
housing 12. The sealing surface distance safety design of this
invention further reduces the likelihood of body fluid leaking out
from inside the tubular cartridge exchange platform device 10 from
between the engaged sealing surfaces of the platform housing 12 and
the sealing surface of the inserted tubular cartridge insert 32 and
44, whether or not the cartridge inserts 32 and 44 are fixed into
proper body fluid communication alignment within the platform
housing 12, and whether or not the cartridge inserts 32 and 44 are
in exchange transition partially into or partially out from a
portion of the interior tubular wall surface of the platform
housing 12.
This sealing surface design configuration of the cartridge inserts
32 and 44 can be further enhanced to prevent body fluid leakage out
from between the cartridge insert sealing surface and the interior
wall surface of the platform housing 12, by use of one or more
thermoplastic elastomers on a portion of the tubular cartridge
insert sealing surface, or by the use of one or more thermoplastic
elastomers as a structural assembly component or part of the
internal flow path sealing surface or port openings, located on the
sealing surface of the tubular cartridge insert 32 or 44.
FIGS. 5A, 5B, and 5C, further illustrate an example of the first
and second leg member proximal port opening 16 and 20 offset
arrangement to each other and the offset port opening alignment
relationship of the first and second sealing surface port openings
36 and 38 of the tubular cartridge insert 32. More specifically, if
a line is drawn parallel to a center axis (axis A--A) of the
interior lumen of the tubular platform housing 12 from the first
platform housing opening 28 to the second platform housing opening
30, the line can pass between both the first leg member proximal
port opening 24 and the second leg member proximal port opening 26,
without intersecting either leg member proximal port opening 24 or
26. The line A--A represents the bi-directional movement path a
tubular cartridge insert follows during insertion and removal from
inside the tubular sealing surface of the platform housing 12. The
offset position of the second leg member proximal port opening 26
relative to the first leg member proximal port opening 24 as shown,
facilitates the insertion, exchange and removal of a sealably
engaging tubular cartridge insert 32, containing one or more
sealing surface port openings, without continuous leakage of body
fluid between the interior wall surface of the cartridge exchange
platform device 10.
FIG. 5B shows the primary cartridge insert 32 being removed through
the first opening 28 of the platform housing 12. As the primary
cartridge insert 32 moves out from inside of the platform housing
12, the second sealing surface port opening 38 is sufficiently
offset such that it does not intersect with the first leg member
proximal port opening 24 when the cartridge insert 32 is moved in
either a forward or backward direction. Likewise, in FIG. 5C, the
first sealing surface port opening 36 of the tubular cartridge
insert 32 does not intersect with the second leg member proximal
port opening 26 of the platform housing 12 as the primary cartridge
insert 32 moves in or out through the second platform housing
tubular opening 30.
The placement of the first and second leg member proximal port
openings 24 and 26 relative to the first and second sealing surface
port openings 36 and 38 of the primary cartridge insert 32 are also
representative of the first and second leg member proximal port
openings 24 and 26 relative to the first and second sealing surface
port openings 48 and 50 of the secondary cartridge insert 44 (see
FIG. 6). As either the primary cartridge insert 32 or the secondary
cartridge insert 44 is pushed by the user into the interior lumen
of the platform housing 12 of the cartridge exchange platform
device 10, none of the internal flow path port openings located in
the sealing surface of the cartridge insert (e.g., the first or
second sealing surface port openings 36 or 38 in the tubular
cartridge insert 32, or the first or second sealing surface port
openings 48 or 50 in the secondary cartridge insert 44) pass over a
leg member proximal port opening 24 or 26 inside the tubular
platform housing other than the proper leg member proximal port
opening with which it is designed to align and couple for
completing body fluid communication between the first and second
leg member internal passageways 16 and 20, once the cartridge
insert 32 or 44 reach their intended fixed position within the
cartridge exchange platform device 10.
FIG. 6 illustrates a perspective view of the minimally invasive
cartridge exchange platform device 10 along with two examples of a
body fluid communicating cartridge insert, a primary cartridge
insert 32 for non-external body fluid communication and simple
continuous fluid flow within the cartridge exchange platform device
10, and a secondary cartridge insert 44 for external body fluid
communication out from the cartridge exchange platform device 10
via connection to any number of medical treatment devices. The
platform housing 12 is shown in perspective view with the generally
oval cross-section hollow interior. The first hollow leg member 14
is viewable from this perspective; however, the second hollow leg
member 18 is substantially hidden behind the platform housing 12 of
the cartridge exchange platform device 10. The first leg member
proximal port opening 24 and the second leg member port opening 26
provide fluid communication into the interior wall surface inside
the platform housing 12 lumen. The first leg member 14 includes a
first internal passageway 16 and a distal port opening 40, and
extends outward from the platform housing 12 and can be further
oriented in a downward direction for a particular clinical
purpose.
The secondary cartridge insert 44 is one example of an externally
connectable device illustrated in FIG. 6. The particular secondary
cartridge insert 44 illustrated is designed to provide external
body fluid communication from a first leg member internal
passageway 16 of the cartridge exchange platform device 10, through
a first sealing surface external port opening 48 and external flow
path 52, and then out through the first external port opening 51 of
the secondary cartridge insert 44 to an externally connected
medical treatment device. Following external treatment, body fluid
is returned back into the secondary cartridge insert 44 through the
second external port opening 53 and external flow path 54 and
through the second sealing surface external port opening 50 of the
secondary cartridge insert 44, and then into the second leg member
internal passageway 20 of the cartridge exchange platform device
10. The external medical treatment device can be, for example, a
dialysis machine 72 (see FIG. 8).
The secondary cartridge insert 44 has a cross-section generally
compatible with the cross-section of the platform housing 12, which
in the illustrated embodiment is generally oval. The secondary
cartridge insert 44 includes a first sealing surface external port
opening 48 and a second sealing surface external port opening 50
that communicate to a non-sealing external cartridge insert surface
that is directed outward from the inside area of the platform
housing 12 by one or more external passageways 51 and 53. The first
sealing surface external port opening 48 facilitates body fluid
communication with a first external passageway 52, while the second
sealing surface external port opening 50 facilitates body fluid
communication with a second external passageway 54. The secondary
cartridge insert 44 additionally includes a first non-sealing
surface external port opening 51 and a second non-sealing surface
external port opening 53. The first and second external port
openings 51 and 53 also provide fluid communication from outside
the secondary cartridge insert 44 to an interior portion of the
secondary cartridge insert 44. The first external passageway 52
communicates with the first external port opening 51 and to the
first sealing surface external port opening 48. The second external
passageway 54 communicates with the second external port opening 53
and to the second sealing surface external port opening 50.
To provide the patient external medical treatment access to
internal body fluids with the cartridge exchange platform device 10
the secondary cartridge insert 44 is inserted into the interior
portion of the platform housing 12 through the first platform
housing opening 28 or the second platform housing opening 30,
depending on the internal arrangement, alignment direction and or
proper fluid communication orientation of the first sealing surface
external port opening 48 and the second sealing surface external
port opening 50 of the secondary cartridge insert 44. More
specifically, if the secondary cartridge 44 sealing surface
external port openings 48 and 50 are sized, dimensioned, shaped and
disposed to smoothly couple with the first and second leg member
proximal port openings 24 and 26 of the platform housing 12, upon
insertion of the secondary cartridge insert 44 by the user through
the first platform housing opening 28, then the secondary cartridge
insert cannot be inserted through the second platform housing
opening 30 of the cartridge exchange platform device 10 because the
sealing surface port openings 48 and 50 would not align
appropriately with the first and second leg member proximal port
openings 24 and 26 inside the platform housing 12, thereby
preventing internal body fluids from communicating outside of the
cartridge exchange platform device 10. The secondary cartridge
insert 44 is designed to prevent improper installation into the
platform housing 12 by one externally disposed end being larger
than the internal cross-section of the platform housing 12 and the
platform housing openings 28 and 30, so that the proper insertion
direction or the secondary cartridge insert 44 cannot be
accidentally installed in a reversed or improper direction by the
user and into the platform housing openings 28 or 30, or be
inserted inappropriately from the proper direction it is designed
to functionally align internally with, once installed inside the
platform housing 12, without turning the secondary cartridge insert
44 around 180 degrees to fit the cartridge insert 44 into the
platform housing 12. This change of direction of the secondary
cartridge insert 44 would cause the first and second sealing
surface port openings 48 and 50 to miss their intended alignment
location with the first and second leg member proximal port
openings 24 and 26 of the platform housing 12 because of the offset
arrangement of the first and second leg member proximal port
openings 24 and 26. If the secondary cartridge insert 44 did not
have an externally disposed cartridge insert section or portion
larger than the cross-section of the platform housing 12 first and
second platform housing openings 28 and 30, the secondary cartridge
insert 44 could be inserted incorrectly by the user through either
the first or second platform housing openings 28 or 30.
The enlarged externally disposed section of the secondary cartridge
insert 44 further serves to make the insertion and removal of the
secondary cartridge insert 44 functionally easier to install by the
user in a forward directed motion into the cartridge exchange
platform device 10 by providing a larger tactile surface feature
for the user to grasp and handle while working with the secondary
cartridge insert 44. In addition, tactile ridges and or
indentations 55 are provided on the larger externally disposed
section of the secondary cartridge insert 44 for more secure
gripping of the secondary cartridge insert 44 by the user. Such
improvements can apply to any of the cartridge inserts used with
the body fluid cartridge exchange platform device 10 of the present
invention.
When the secondary cartridge insert 44 is installed in the proper
insertion direction for first and second sealing surface external
port opening 48 and 50 alignment into the platform housing 12 of
the cartridge exchange platform device 10, the first sealing
surface external port opening 48 comes into alignment with the
first leg member proximal port opening 24 and the second sealing
surface external port opening 50 comes into alignment with the
second leg member proximal port opening 26. Once the secondary
cartridge insert 44 reaches its fixed and intended position inside
the platform housing 12, the secondary cartridge insert 44
facilitates body fluid communication between the first leg member
14 via the first leg member internal passageway 16 and the first
leg member proximal port opening 24, through the first sealing
surface external port opening 48 and external passageway 52, and to
the first external port opening 51. Likewise, when the secondary
cartridge insert 44 is positioned at its fixed intended position
inside the platform housing 12, the coupled internal flow paths,
channels or passageways of the cartridge exchange platform device
10 complete a fluid circuit arrangement within the secondary
cartridge insert 44 and facilitate fluid communication between the
second leg member 18 via the second leg member internal passageway
20 and the second leg member proximal port opening 26, through the
second sealing surface external port opening 50 and external
passageway 54, and to the second external port opening 53. The
tubular secondary cartridge insert 44 sealably engages with a
portion of the interior wall surface of the platform housing 12,
hindering leakage of body fluids traversing through the external
flow paths 52 and 54 of the secondary cartridge insert 44 and the
cartridge exchange platform device 10. FIG. 8 further illustrates
one example of implementation of the secondary cartridge insert 44
installed in an operable and fixed condition, inside the cartridge
exchange platform device 10, for the purposes of providing internal
body fluid communication with an externally connected medical
treatment apparatus, e.g. a dialysis machine.
Another example of a tubular cartridge insert as illustrated in
FIG. 6 is the primary cartridge insert 32. The primary cartridge
insert 32 maintains a generally oval or elliptical cross-section
profile that is compatible with the interior tubular cross-section
profile of the platform housing 12 of the cartridge exchange
platform device 10. The primary cartridge insert 32 includes a
first sealing surface port opening 36 and a second sealing surface
port opening 38. The primary cartridge insert 32 further includes
an internal fluid communicating flow path, channel or passageway
34, between the first sealing surface port opening 36 and the
second sealing surface port opening 38.
The primary cartridge insert 32 has a different user purpose than
the secondary cartridge insert 44, and therefore the primary
cartridge insert 32 has been designed to be properly installed into
the platform housing 12 through either of the two housing platform
openings, either through the first platform housing opening 28 or
the second platform housing opening 30, interchangeably. Because
the cross-section of the tubular form primary cartridge insert 32
is not greater dimensionally at any point than the cross-section of
the platform housing 12 other than the depressible locking tab 62,
which can extend radially out beyond the sealing surface if the
cartridge insert 32, the previously discussed issue of not being
able to use either platform housing opening 28 or 30 with the
secondary cartridge insert 44 does not apply to the primary
cartridge insert 32 or its use with the cartridge exchange platform
device 10. The primary cartridge insert 32 is designed to be
inserted bi-directionally through either the first or second
platform housing openings 28 or 30 and when the primary cartridge
insert 32 first and second sealing surface port openings 36 and 38
are oriented properly to align with the platform housing's first
and second leg member proximal port openings 24 and 26.
As designed, the primary cartridge insert 32 sealably engages with
a portion of the interior tubular wall surface of the platform
housing 12 to ensure a leak-proof seal during insertion inside the
cartridge exchange platform device 10. The primary cartridge insert
32 sealing surface engagement with the interior tubular wall
surface of the platform housing 12 is made to prevent leakage of
flowing body fluids out from the first and second leg members
internal passageways 16 and 20 and respective proximal port
openings 24 and 26 to the outside surface of the cartridge exchange
platform device 10 during cartridge insert 32 movement, insertion,
replacement or removal from the interior wall surface of the
platform housing 12, or by forward directed movement and contact
from a second cartridge insert 32 or 44 device inserted into the
interior tubular wall surface of the platform housing 12. As the
primary cartridge insert 32 is installed by the user by forward
directed movement toward the intended fixed position within the
cartridge exchange platform device 10, the first sealing surface
port opening 36 of the primary cartridge insert 32 comes into fluid
communication alignment with the first leg member proximal port
opening 24 of the platform housing 12. Simultaneous to the same
forward directed movement of the cartridge insert 32 toward the
intended fixed position within the cartridge exchange platform
device 10, the second sealing surface port opening 38 of the
primary cartridge insert 32 comes into fluid communication
alignment with the second leg member proximal port opening 26 cf
the platform housing 12.
Once the cartridge insert 32 reaches its intended fixed position
within interior tubular wall surface of the platform housing 12,
the primary cartridge insert 32 first and second sealing surface
port openings 36 and 38 couple in alignment with the first and
second leg member proximal port openings 24 and 26 of the platform
housing 12 to complete the body fluid communicating flow path
inside the cartridge exchange platform device 10. The complete body
fluid communicating flow path internal to the cartridge exchange
platform device 10 established by proper installation and alignment
of the cartridge insert 32 begins at the first leg member distal
port opening 40 and continues through to the first leg member
internal passageway 16 and proximal port opening 24 coupled in
alignment with cartridge insert 32 first sealing surface port
opening 36. The path further communicates through to the internal
flow path 34 and second sealing surface port opening 38 coupled and
aligned with the second leg member proximal port opening 26. The
path further communicates through the second leg member internal
passageway 20 and distal port opening 42 to complete the cartridge
exchange platform device 10 internal fluid flow path.
One of ordinary skill in the art will understand and appreciate
that the oval or elliptical cross-section illustrated for the
tubular formed cartridge exchange platform device 10 and tubular
formed cartridge inserts 32 and 44 can have many different annular
cross-section profiles. For example, the elliptical cross-section
profile of the platform housing 12 and the first and second
platform housing openings 28 and 30 can be made non-elliptical by
being formed into a circular, rectangular, square, triangular, or
even non-uniform annular profile, such as an annular cross-section
profile including notches, dimples, indentations, straight and
curved portions, or the like. Each annular shape has benefits and
disadvantages associated therewith. Any cartridge insert that is
part of the complete body fluid communicating flow path inside the
cartridge exchange platform device 10, such as the secondary
cartridge insert 44 as one example, must have an annular
cross-section profile to facilitate sealing engagement with a
portion of interior tubular wall surface of the platform housing
12, following insertion of the secondary cartridge insert 44 into a
portion of the hollow platform housing 12. The corresponding
annular cross-section profile of a cartridge insert made part of
the cartridge exchange platform device 10 does not need to be
identical in cross-section shape or profile to the outer wall
surface shape or profile of the platform housing 12, it need only
be made sized to a dimension and cross-section profile in a manner
to facilitate the sealing engagement of a portion of the cartridge
insert 32 or 44 sealing surface to the interior wall surface of the
platform housing 12 to hinder leakage of body fluids traversing
through the cartridge exchange platform device 10.
The oval cross-section profile shown in the illustrated embodiments
of the present invention aids in the proper alignment of cartridge
inserts 32 or 44 that are inserted into the platform housing 12 of
the cartridge exchange platform device 10, without sacrificing ease
of cartridge insert exchange. The elliptical tubular surface inside
of the oval platform housing 12 avoids the existence of interior
corners, which are more difficult to attain cartridge insert 32 or
44 sealing surface engagement and sealing surface port opening 36
and 38 alignment with the first and second leg member proximal port
openings 24 and 26 in the interior wall surface of the platform
housing 12 to prevent flowing or continuous body fluid leakage from
occurring during cartridge insert 32 or 44 exchange, and to further
maintain an easy to clean interior wall surface environment inside
the oval cartridge exchange platform device 10. The oval shape also
allows any cartridge insert that is made part of the body fluid
cartridge exchange platform invention having the corresponding oval
profile cross-section to be inserted in only one of two positions,
a first position and a second position 180 degrees in rotation from
the first position. It is not possible to insert a cartridge insert
having a corresponding oval profile in a manner where it is
miss-aligned by a partial rotation between 0 and 180 degrees. Other
different cross-section profile shapes can incorporate this annular
alignment feature, however it is not necessary for operation of the
present invention, so long as a portion of the inserted cartridge
insert 32 and 44 of the cartridge exchange platform device 10 is
appropriately oriented to provide body fluid communication upon
insertion to its corresponding fixed and intended position within
the cartridge exchange platform device 10, as described herein. The
oval cross-section profile additionally provides sufficient sealing
surface volume and radial surface area width to maximize offset
placement of the first and second leg member proximal port openings
24 and 26 inside the platform housing 12 in the smallest
cross-sectional area suitable for maximizing the arcuate internal
flow path cross-section area inside the internal flow path 34 of
the cartridge insert 32 for body fluid to uniformly traverse and
flow through the cartridge exchange platform device 10.
FIG. 7 further illustrates two different examples of possible
purpose cartridge inserts having either internal or external fluid
communicating flow paths, channels, or passageways made to function
and sealably engage with the hollow cartridge platform housing 12
as shown in the perspective illustration of FIG. 6 from a viewpoint
underneath the body fluid cartridge exchange platform device 10. As
can be seen in FIG. 7, the primary cartridge insert 32 is sized,
shaped, and dimensioned to fit within the first or second openings
28 or 30 of the hollow cartridge platform housing 12. Once the
primary cartridge insert 32 is inserted and installed into its
intended fixed position within the hollow cartridge platform
housing 12 by moving the primary cartridge insert 32 from left to
right into the first opening 30, the first sealing surface port
opening 36 and the second sealing surface port opening 38 of the
primary cartridge insert 32 align with and couple to the first leg
member proximal port opening 24 of the first leg member 14. This
occurs generally contemporaneously with the alignment with and
coupling to the second leg member proximal port opening 26 of the
second leg member 18 of the hollow cartridge platform housing 12.
Thus, a complete body fluid communicating flow path is formed
inside the body fluid cartridge exchange platform device 10
originating from the first leg member distal port opening 40 of the
first leg member 14, through the corresponding internal passageway
16, through the internal flow path 34 of the primary cartridge
insert 32, through the second leg member internal passageway 20 of
the second leg member 18, and out through the second leg member
distal port opening 42. This fluid communicating flow path
direction is reversible from the second leg member 18 to the first
leg member 14 of the hollow cartridge platform housing 12,
depending on the clinical requirements of the patient and desired
direction of body fluid flow through the body fluid cartridge
exchange platform device 10.
When the patient requires use of the secondary cartridge insert 44
for external body fluid communication for medical treatment with
the body fluid cartridge exchange platform device 10, the secondary
cartridge insert 44 as illustrated in FIG. 7 is inserted by forward
directed movement into the second opening 30 of the hollow
cartridge platform housing 12 by forward directed contact and
displacement of the primary cartridge insert 32 following release
of any locking tab engagement within the hollow cartridge platform
housing 12 by the user. As the secondary cartridge insert 44 is
moved into its intended fixed position within the hollow cartridge
platform housing 12, the first sealing surface external port
opening 48 and the second sealing surface external port opening 50
come into body fluid communication alignment with the first leg
member proximal port opening 24 of the first leg member 14 and
second leg member internal passageway 1, generally simultaneous to
the second leg member proximal port opening 26 of the second leg
member 18 and corresponding internal passageway 20 of the cartridge
platform housing 12. Once the secondary cartridge insert 44 is
installed to its intended fixed position, the first leg member
internal passageway 16 aligns to form an external body fluid
communication flow path with the first external flow path, channel,
or passageway 52 and the first non-sealing surface external port
opening 51 of the secondary cartridge insert 44. Likewise, the
second leg member internal passageway 20 of the hollow cartridge
platform housing 20 aligns to form an external body fluid
communication flow path with the second external flow path,
channel, or passageway 54 and the second non-sealing surface
external port opening 53 of the of the secondary cartridge insert
44.
When the primary cartridge insert 32 is fully installed or inserted
by the user to its fixed and operable destination within the hollow
cartridge platform housing 12, the internal flow path, channel, or
passageway 34 of the cartridge insert 32 provides a body fluid
communicating circuit between the first leg member 14 and
corresponding internal passageway 16 with the second leg member 18
and corresponding internal passageway 20 inside the body fluid
cartridge exchange platform device 10. Therefore, any body fluid,
including blood that flows through and/or communicates with the
first leg member 14 and first leg member internal passageway 16,
must also communicate with and/or flow through the internal flow
path, channel, or passageway 34 of the primary cartridge insert 32
and further flow through and/or communicate with the second leg
member 18 and second leg member internal passageway 20 of the body
fluid cartridge exchange platform device 10. Thus, for example, the
first leg member 14 can communicate with an artery or first body
fluid organ within a patient, and the second leg member 18 can
communicate with a vein or second body fluid organ within the
patient. In such an arrangement, the body fluid or blood
communicates with or flows through the first internal passageway 16
of the first leg member 14, and must communicate with or flow
through the internal flow path, channel, or passageway 34 of the
primary cartridge insert 32, and further flow through and or
communicate with the second leg member 18 and second leg member
internal passageway 20, and into the vein or second body fluid
organ within the patient. The primary cartridge insert 32 as a
component of the body fluid cartridge exchange platform device 10
is therefore a continuous body fluid organ communicating cartridge
insert for medical use with one or more internal body fluid organs
during periods of time when the patient does not require external
body fluid communication and connection to any number of external
medical treatment devices.
When the secondary cartridge insert 44 is installed inside the
hollow cartridge platform housing 12 to its fixed and intended
operable position, a different body fluid communicating arrangement
and/or flow path configuration is created between the first and
second leg members 14 and 18 by the secondary cartridge insert 44
inside the body fluid cartridge exchange platform device 10 than
the body fluid communicating arrangement and/or internal flow path
of the primary cartridge insert 32. If, for example, the first leg
member 14 communicates with an artery of the patient and the second
leg member 18 communicates with a vein of the patient, the flow
path and fluid direction of the blood traverses the first internal
passageway 16 of the first leg member 14 toward the second internal
passageway 20 of the second leg member 18 by completion of a fluid
circuit within the platform housing 12 by an installed cartridge
insert 32. However, with the secondary cartridge insert 44
installed inside the platform housing 12, the body fluid or blood
traverses from the first internal passageway 16 of the first leg
member 14 and into the first external flow path 52 of the secondary
cartridge insert 44. Such a body fluid communicating arrangement or
flow path configuration made by the installation of the secondary
cartridge insert 44 inside the hollow cartridge platform housing 12
allows the body fluid to exit through and communicate with the
first non-sealing external surface port opening 51 to whatever
external medical treatment method or device the secondary cartridge
insert 44 is connected. When the connected external medical
treatment device returns the body fluid back through the second
non-sealing surface external port opening 53 and into the external
flow path 54 of the secondary cartridge insert 44, fluid flow
continues out through the second sealing surface external port
opening 50, into the second leg member proximal port opening 26 and
into the second internal passageway 20 of the second leg member 18.
Therefore, the body fluid or blood flow supplied from the first and
second leg members 14 and 18 of the body fluid cartridge exchange
platform device 10, that communicates with and traverses through
and installed secondary cartridge insert 44, undergoes a different
body fluid communicating flow circuit and external flow path
configuration when required by the patient for external medical
treatment, e.g., dialysis.
FIG. 8 provides a detailed illustration of one example of how body
fluid cartridge exchange platform device 10 is implanted
percutaneously through the skin utilizing minimally invasive
surgical techniques to an arm 78 of a patient in accordance with
the teachings of the present invention. A portion of the small
diameter first leg member 14 and a portion of the small diameter
second leg member 18 of the body fluid cartridge exchange platform
device 10 penetrate through the skin of the arm 78 of the patient.
As can be seen, the limited amount of surface area surrounding each
leg member 14 and 18 that makes physical contact with the topical
skin surface and further requires wound healing after implantation
of the body fluid cartridge exchange platform device 10 is
substantially smaller than a surface area surrounding the main body
platform housing 12 of the body fluid cartridge exchange platform
device 10. In addition, placement of the first percutaneous wound
in the patient's arm 78 for a portion of the first leg member 14 at
a separate or distal location from the second percutaneous wound of
a portion of the second leg member 18 and further separated by a
distance or section of healthy, non-surgically effected, skin
tissue, such that if the first percutaneous wound becomes topically
infected, there is a significantly smaller likelihood of the
infection spreading to the second percutaneous wound.
As illustrated in FIG. 8, the surgically installed body fluid
cartridge exchange platform device 10 demonstrates one example of
how a portion of the first leg member 14 couples subcutaneously
with a first organ communicating means 84, while a portion of the
second leg member 18 couples with a second organ communicating
means 86 below the epidermis of the patient's arm 78. The first and
second organ communicating means 84 and 86 can have many different
connection and attachment mechanisms, synthetic vascular graft and
suture material, rare earth or allow metal material, natural
tissue, and/or medical grade plastic tubing suitable for
implantation. The first organ communicating means 84 couples with a
first body fluid organ 80 of the patient, while the second organ
communicating means 86 further couples with a second body fluid
organ 82 of the patient. In another embodiment of the invention,
the first organ communicating means 84 couples to the first body
fluid organ 80 and the second organ communicating means further
couples to the same first body fluid organ 80.
As further illustrated in FIG. 8, the majority of the external
surface area of the body fluid cartridge exchange platform device
10 resides above the skin of the patient following implantation and
is shown with the secondary exchange cartridge insert 44 installed
into the body fluid cartridge exchange platform device 10 and
connected to an external medical treatment apparatus 72 via
connected medical treatment tubes 74 and 76. A first medical
treatment tube 74 couples with the first non-sealing surface
external port opening 51 and a second medical treatment tube 76
couples with the second non-sealing surface external port opening
52 to provide body fluid communication external to the secondary
exchange cartridge insert 44 from inside the body fluid cartridge
exchange platform device 10. The first and second medical treatment
tubes 74 and 76 additionally couple with the external medical
treatment apparatus 72, which is a dialysis machine in the
illustrated embodiment. One of ordinary skill in the art will
appreciate that the dialysis machine is merely one example of an
external medical apparatus 72 that can make use of the body fluid
cartridge exchange platform device 10 of the present invention.
Other medical treatment devices that can be used with the body
fluid cartridge exchange platform device 10 include devices for
delivering medication, devices for delivering nourishment, devices
for temperature regulation and oxygenation, and devices for
invasively monitoring body fluid content and/or function.
In operation, the body fluid or blood flows from the body fluid
organ or artery 80, through the first organ communicating means 84
and the first internal passageway 16 of the first leg member 14,
and out through the first external flow path 52 of the secondary
exchange cartridge insert 44. The secondary exchange cartridge
insert 44 then directs the body fluid or blood flow out through the
first non-sealing surface external port opening 51, through the
first medical treatment tube 74, and to the dialysis machine 72.
The dialysis machine 72 filters the blood, and returns it back to
the secondary exchange cartridge insert 44 through the second
medical treatment tube 76 and into the second non-sealing surface
external port opening 53. The secondary exchange cartridge insert
44 receives the returning blood through the second external flow
path 54 and then directs the blood out of the secondary cartridge
insert 44 and into the second internal passageway 20 of the second
leg member 18 of the body fluid cartridge exchange platform device
10, through the second organ communicating means 86, and into the
second body fluid organ or vein 82 of the patient. When dialysis
treatment is complete, the first and second medical treatment tubes
74 and 76 are clamped off and disconnected from the dialysis
machine so that the user can then remove and exchange the secondary
cartridge insert 44 by insertion of the primary cartridge 32 to
resume circulation of the blood flow from the body fluid organ or
artery 80 directly to the vein 82 when the patient no longer
requires connection to external medical treatment.
FIGS. 9A, 9B, and 9C show two examples of the various cartridge
inserts that can be installed into the hollow cartridge platform
housing 12 in a manner illustrating the swapping or bi-directional
exchange of one cartridge insert for another. FIG. 9A begins with
the secondary exchange cartridge insert 44 installed and locked
within the hollow cartridge platform housing 12. The primary
cartridge insert 32 is positioned to enter the hollow cartridge
platform housing 12 through the second opening 30. As this occurs,
the user depresses the locking tab 62 of the indwelling secondary
cartridge insert 44 through the second receiver 60 in the wall of
the hollow cartridge platform housing 12, so that the primary
cartridge insert 32 can be pushed in a forward directed motion to
push and/or displace the secondary cartridge insert 44 out through
the first platform housing opening 28 of the body fluid cartridge
exchange platform device 10. FIG. 9B illustrates the secondary
cartridge insert 44 having been removed from the hollow cartridge
platform housing 12, while the primary cartridge insert 32 is
resident within the internal hollow portion of the hollow cartridge
platform housing 12, and the locking tab 62 is in place within the
second receiver 60. FIG. 9C illustrates a perspective view of the
primary cartridge insert 32 contained and locked in place within
the hollow structure of the hollow cartridge platform housing 12.
The progression illustrated in FIGS. 9A, 9B, and 9C is reversible
in that with the primary cartridge insert 32 installed, the
secondary cartridge insert 44 can be inserted in the second housing
opening 30 to push and displace the primary cartridge insert 32 out
of the hollow cartridge platform housing 12 through the first
housing opening 28, provided the locking tab 62 is depressed
sufficiently to allow the primary cartridge insert 32 to be
released and moved by direct contact with the secondary cartridge
insert 44.
FIGS. 10A and 10B illustrate an example of a cartridge insert
exchange tool 66 for exchanging cartridge inserts within the hollow
cartridge platform housing 12. The cartridge insert exchange tool
66 includes a set of grips 68 that are pinched together by the user
to allow a clamp 70 to fit over a portion of the hollow cartridge
platform housing 12. Once the cartridge insert exchange tool 66 is
positioned on top of the hollow cartridge platform housing 12, the
grips 68 are related by the user to allow the clamp 70 to attach
to, and enclose, a portion of the hollow cartridge platform housing
12. A portion of the hinged clamp is made to come into direct
contact with a portion of the indwelling locking tab 62 contained
within the second receiver 60 upon enclosure of the hollow
cartridge platform housing 12 by the insert exchange tool 66 to
depress the locking tab 62 to facilitate its release and subsequent
cartridge insert exchange. As a cartridge insert 72 exits the
hollow cartridge platform housing 12 by the forward directed
movement of a second cartridge insert, the first cartridge insert
72 enters an expired insert containment chamber located within an
internal portion of the insert exchange tool 66. Once the expired
first cartridge insert 72 has been completely displaced and removed
from the hollow cartridge platform housing 12 and contained in
place within the containment chamber of the insert exchange tool
66, the user pinches the grips 68 to release the clamp 70 from the
hollow cartridge platform housing 12 to allow the user to lift and
remove the insert exchange tool 66 from the body fluid cartridge
exchange platform device 10 for subsequent disposal.
To aid in the insertion and removal of cartridge inserts, the
cartridge insert exchange tool 66 can also contain a marking 71
acting as a direction indicator. The marking 71 indicates the
correct arrangement and alignment for insertion of the first
cartridge insert 72 into the platform housing 12. The location of
the marking 71 on the cartridge insert exchange tool 66 can vary to
maximize its usefulness and the ability of a user to see the
marking 71.
The primary cartridge insert 32 and the secondary cartridge insert
44 are merely two possible cartridge insert configurations made
possible for use in conjunction with the present invention. It is
anticipated that a number of different cartridge insert purposes
will require different body fluid communication geometries and
configurations, which can be utilized in conjunction with the body
fluid cartridge exchange platform device 10 of the present
invention.
The leg members 14 and 16 of the present invention as disclosed
herein facilitate the majority of the externally cleanable surface
area and all cartridge insert physical exchange areas of the hollow
cartridge platform housing 12 remaining external to the body of the
patient, while only portions of the leg members and 14 and 18
penetrate the skin of the patient for body fluid communication with
internal organs. This external body fluid cartridge exchange
platform device 10 of the present invention reduces the potential
contact and source of infection complications that can come from
direct topical skin contact with the moving parts of the body fluid
communicating cartridge inserts and the hollow cartridge platform
housing openings, which facilitate external to the body cartridge
insert exchange. This minimally invasive percutaneous implant
device also reduces pain and touch sensitivity to handling or
manipulation of the hollow cartridge platform housing or cartridge
inserts during insertion and removal of the cartridge inserts and
connection to external medical treatment devices. The raised hollow
cartridge platform housing is placed substantially horizontal to
the skin surface, providing space underneath the raised platform of
the hollow cartridge platform housing for natural movement of the
skin and/or moderate movement of the body fluid cartridge exchange
platform device from side to side, in addition to providing
adequate access for hygienic care of the patient's skin around the
percutaneous leg members. The ability to make the raised platform
hollow cartridge platform housing and corresponding cartridge
inserts and engageable sealable surfaces all tubular, facilitates
the exchange of cartridge inserts with a simplified bi-directional
arrangement. The sealing surface distance between the end openings
of the hollow cartridge platform housing and the sealing surface
port openings inside the tubular platform housing, which
communicate with the internal body fluid passageways creates a leak
proof cartridge insert method to install and/or exchange one
cartridge insert for another without loss of body fluids or
infiltration of airborne particles to the internal flow paths,
channels, or passageways inside the body fluid cartridge exchange
platform device. Changeable cartridge inserts can be sealably
contained within the hollow cartridge platform housing by making
the external portion of the raised platform hollow cartridge
platform housing open at each end for bi-directional insertion
and/or exchange of different cartridge inserts. The incorporation
of one or more internal flow paths, channels, or passageways in the
body fluid cartridge exchange platform device that communicate
directly to and connect with external devices provides safe and
simplified external access to the internal body fluid organs of a
patient for medical, diagnostic, or therapeutic purposes.
Numerous modifications and alternative embodiments of the present
invention will be apparent to those skilled in the art in view of
the foregoing description. Accordingly, this description is to be
construed as illustrative only and is for the purpose of teaching
those skilled in the art the best mode for carrying out the present
invention. Details of the structure may vary substantially without
departing from the spirit of the invention, and exclusive use of
all modifications that come within the scope of the appended claims
is reserved. It is intended that the present invention be limited
only to the extent required by the appended claims and the
applicable rules of law.
* * * * *